Sebastian Baumann

Dear Ladies and Gentlemen, 

My objective is to develop my career further within your company; therefore, I am applying for the position in “Regulatory Affairs Manager”.

I have an Engineering Diploma in biotechnology and have been working for more than 15 years in the pharmaceutical industry, working in various positions from research, production, quality and global regulatory affairs on a broad variety of products covering Rx and OTC medicine, food and food supplements, cosmetics, drug medical device combination, medical device/software, in vitro diagnostic products, combination products, CEP and DMF as well small and large molecules including biosimilars. 

I started my journey as a research scientist at AstraZeneca in Sweden where I worked under GLP on transient expression of mammalian cells. Then I worked under cGMP in the manufacturing pilot plant of biopharmaceuticals for GSK in the UK. I then had the chance to get further experience within the technical services department for Baxter Bioscience SA in Neuchatel where I took part in the preparation of protocols for CAPA issues. Another important aspect of the position was to prepare campaign reports in close collaboration with the quality assurance department to document and analyse the deviations and change requests in the manufacturing process.

I have gathered various regulatory and CMC experiences within Novartis Consumer Health and Pharma, Switzerland within the marketed and development unit for small molecules for different therapeutic areas including oncology. In this role, I have gained major experiences in working with various stakeholders i.e. Heath Authorities like FDA, Japanese and EU Health Authorities including EMA and with 3rd party development partners. 

Later on, I worked as a Regulatory Affairs Manager in Reg.CMC for F.Hoffmann La-Roche Ltd. in Basel, Switzerland, focusing first on the small molecules and developing than within the large molecules department (for haemophilia and oncology therapeutic areas for global registrations), working as core CMC members within project teams. Moreover, I have been taking part into a job rotation initiative within the Roche Quality Operation at Kaiseraugst for global clinical supply where I could gain experience in Quality aspects while providing insights on CMC regulatory needs. Later, I have been working as a Regulatory Affairs Compliance Leader at Spirig Galderma HealthCare AG on regulatory aspects of OTC, cosmetics, medical devices as well on food supplements. In this role, I have been working on developing registration dossiers for global and regional roll-outs. I have working in close collaboration with procurement for raw material purchasing and responsible for internal audits and batch review compliance checks. Moreover, I was also developing SOPs to standardise process flows and manufacturing processes and I was leading a team for a critical project on industrialization of cosmetics. In addition, I was leading a project to establish a DMF.  

Currently I am a Regulatory Affairs Manager at Colgate Palmolive overseeing and implementing regulatory registration strategies ensuring regulatory compliance for all products in a complex and changing global regulatory environment including line extension projects. 

My progressions through several positions in the pharmaceutical industry have given me the opportunity to interact with various departments, to increase role in regulatory affairs while acquiring expertise in Quality Assurance. I gained experience on various product developments managing multiple challenges with proven ability to articulate clearly strategies, risks and options. I have worked in many occasions on project involving external development partners from various geographies (i.e. US, EU and Japan) and could demonstrate excellent collaboration skills.

The position as “Regulatory Affairs Manager” within your company would allow me to develop my professional experience into new product areas, while making best use of all skills and experiences gained within the past years. In addition, I can offer varied language skills being of German mother tongue and fluent in English. I also have a good level in French. 

I am impatient to use all my energy and to invest myself in new challenges that the position as “Regulatory Affairs Manager” would bring. I am a reliable enthusiastic individual who has proven to enjoy and learn fast, expanding knowledge in new product categories and with various regional requirements. Moreover, I am detail oriented, able to work independently with strict self-discipline under limited management supervision.  I also enjoy very much cross-functional teamwork, as well leading and mentoring colleagues. Furthermore, I am used to working on several projects simultaneously in complex fast-moving environment and matrixed organisations. Proof track to work and make the difference in a fast changing and timewise controlled environment within the setup of a highly regulated environment. Ensure that changes in the regulatory landscape are communicated effectively within the team and the corresponding matrix organization.

For further information about my background, please find attached my detailed curriculum vitae.

I hope my application raises your interest and I would highly appreciate if we could arrange an interview to discuss further and I hope to hear from you very soon. The best way to reach me is between 8.30 a.m. to 7.30 p.m. by phone, but you can also send me an e-mail as specified in the letterhead. 

Yours Faithfully,

Sebastian Baumann

Curriculum Vitae

Sebastian Baumann

German - birth date: 28-02-1975

Professional Experience

07.2021– current         Colgate Palmolive, Therwil, Switzerland

                                   Regulatory Affairs Manager

                                   (responsible for EU medicinal drug products and medical devices)

1. Ensure that regulatory strategies and regulatory activities for the EU including CH, UK and Ireland are effectively executed to meet the business objectives and legal requirements, in close collaboration with Regulatory Operations and other internal stakeholders (cosmetics, medicinal products, medical devices and foodstuffs/food supplements).
2. Support in the provision of expert regulatory input to strategic decision making.
3. Site transfer, MAH transfer, labelling update
4. Keep up-to-date with changes in regulatory legislation and guidelines.
5. Support in the development and implementation of regulatory standards that convey the best practices in the regulatory department.
6. Establish strong relationships within the European Division, Regulatory Operations and Global Partners on a cross-functional basis including Marketing, Legal, Technical, Supply Chain, R&D, Regulatory and Product Safety, to ensure alignment and synchronization between Regulatory strategies and Business goals. 
7. Collaborate in regional and global regulatory projects and act as a project manager in the projects assigned independently from the team lead, being responsible for final dossier content and preparation within the agreed timelines
8. Combination products according to article 117 of the MDR
9. Obtaining CE mark, (Annex II, MDR 745/2017), FDA 510k
10. Preparing for UKCA, including selection of UK approved body
    1. Deep knowledge on European Regulatory Procedures (Decentralized, Mutual Recognition & National)
11. Represent Colgate’s interests in the Trade Associations and Consortia in alignment with the defined strategies.
12. Preparation of regulatory opportunities and being part of due diligence participation
13. Share new regulatory trends within the regulatory team and relevant stakeholders
14. Preparing regulatory solutions in complex environments to overcome regulatory issues, thinking out of the box and challenge the status quo
15. Demonstrate leadership within the within the cross functional matrix and within RA, known as the point to go to define regulatory solutions
16. Track and document all regulatory activities in trackers and corresponding databases
17. Being actively part of due diligence activities
    1. Actively monitoring and influence regulatory landscape. Ensure compliance with and/or leverage opportunities resulting from implementation of new legislation for new products under development, ensure that relevant stakeholders are appropriately informed

01.2018 – 06.2021        Ascensia Diabetes Care, Basel, Switzerland

                                   Regulatory Affairs Registration Manager

                                   (responsible for global medical device and IVD registrations)

1. Participate in international industry associations to represent companies position on changing and existing requirements
2. Ensure continued compliance to applicable legislation by close collaboration with internal responsible functions and providing leadership on implementation of changing requirements.
3. Initiate implementation of applicable requirements in new product developments by participation in Global Product Development Teams (Core and Element Teams) to ensure timely launches of high-quality products.
4. Implement an effective regulatory strategy that is cost effective, minimizes barriers for product commercialization and distribution and at the same time does not place at risk company’s compliance stature
5. Provide leadership on any question regarding implantation of International/European standards.
6. Leading the UDI activities with regards to the EU, Turkey, China, Australia and other ROW countries beside US and Canada. 
7. Active member of various internal decision boards to ensure regulatory compliance and companies business support
8. Active member of the MedTech Europe in various workstreams such as implementation preparation of the MDR and IVDR
9. Interaction with Notified Body, discussing tasks to be performed and aligned, preparing Audits and participates to them
10. Share lessons learned with relevant stake holders
11. Support relevant business objectives leading internal and external initiatives
12. Supervises all relevant team activities with regards to team interactions with Competent Authorities or Government bodies
13. Prepare Regulatory Strategy for digital medical devices
14. Keeping up-to date with the relevant guidelines and standards from a global level
15. Coaching newcomer in the RA department
16. Provide input with regards to development projects, renewals and post marketed activities
17. Prepare SWOTS communicate actively risks to the board as appropriate
18. Leading a team of several people and being responsible for  performance management, development, resource allocation and budget

01.2017 – 12.2017        Galderma, Egerkingen, Switzerland

                                   Regulatory Affairs Compliance Project Leader

                                   (temporary contract)

1. Provide regulatory strategies for synthetic marketed products in self-medication, cosmetics, medical devices and food supplements
2. Develop processes for internal and external stakeholders
3. Conduct internal quality audit
4. Supporting external Audits, coordinating Site master file
5. Manage changes (technical, products)
6. Regulatory contribution in purchasing process and decision on raw materials suppliers
7. Project management on industrialization of cosmetics
8. Advice on DMF establishment with an external API manufacturer
9. Working on dermatology product categories in medicinal products, medical devices and cosmetics

01.2016 – 12.2016        F. Hoffmann La-Roche Ltd., Basel, Switzerland

                                   Global Clinical Supply, IMP Quality Operations

                                   job rotation

1. Review and check batch data versus regulation requirements
2. Write and coordinate review of SOPs
3. Establishes process for QP declaration preparation and release

06.2012 – 12.2016        F. Hoffmann La-Roche Ltd., Basel, Switzerland

                                   Pharma Technical Regulatory Manager

                                   (Responsible for pharmaceutical Medicinal products & Medical Devices)

1. Provide strategic leadership and regulatory decision making for synthetic marketed and large molecule development and marketed products in cross-functional product team
2. Develop global Chemistry and Manufacturing Controls (CMC) regulatory strategy from preclinical to global registration 
3. Contributes to change management and guiding cross functional teams for regulatory procedures
4. Manage CMC documentation within the lifecycle maintenance
5. Manage the generation of high-quality regulatory submissions required for the filing of technical changes, renewals and clinical trial applications to health authorities globally including IND/CTA/BLA/MAA
6. Interact with management from multiple internal functional areas, corporate partners, manufacturing sites and international affiliates
7. Facilitate the effective and rapid implementation of technical changes
8. Negotiate successfully with affiliates, partners and health authorities
9. Ensure that submissions authored in the group are of high quality and delivered as per schedule; that content and format of regulatory submissions comply with PTR guidance, applicable regulations, and internal and external guidance governing the development, licensure, and marketing of drugs
10. Utilize established governance processes and lead the resolution of critical issues. In addition, you may oversee outsourced activities and, if needed, provide hands on work in the event that this is required
11. Assess upcoming events (e.g. new strategic priorities, or unplanned events during the implementation of the regulatory strategy) which might have a significant impact on the implementation of the technical change and define/coordinate needed actions (assess risks, identify functions/experts to be involved, support inventory planning) and escalate further up if required
12. Work closely with Roche-internal stakeholders and collaborate when needed with the corresponding/equivalent functions: Regulatory, Quality Assurance, Manufacturing, Quality Control, Validation, Manufacturing Sciences and Technology (MSAT), Supply Chain, DRA, etc.
13. Working on combination products with regards to small and large molecules, ensuring that human factor studies fulfil regulatory requirements for home use
14. Prepare briefing books and leading rehearsals including establishment of a risk mitigation plan (EU/ FDA)
15. Participate and lead scientific advice meetings with various HAs such as FDA, CHMP, PMDA, NMPA including briefing book preparation and leading HA meetings
16. Ensure that registration strategies is aligned with ICH, FDA, and EU CMC guidelines and corresponding requirements
17. Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines. He/she will work collaboratively at the global level, with other group leader in marketed products in the submission and strategy group, to align on priorities and support the achievement of the team and organizational goals, by reallocating resources to support the projects and initiatives on an as needed basis, provides input on quality and analytical development programs

07.2009 – 05.2012        Novartis Pharma AG, Basel, Switzerland

                                   Regulatory CMC Liaison Manager

                                   (permanent assignment responsible for pharmaceutical Medicinal products & Medical Devices)

1. Formulate regional CMC regulatory strategy for assigned development projects or global CMC regulatory strategy for marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance 
2. Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in Reg CMC, DRA, TechOps and TRD as appropriate. 
3. Lead and implement all regional CMC submission activities (planning, review, coordination, submission) for assigned projects/products, while applying the global strategy into regional submissions. 
4. Establish and maintain a single point of contact with FDA or CPOs, DRA EGM, DRA Latam and DRA TA for all communication on development and marketed products. Establish and maintain sound working relationships with partners and customers. 
5. Participate in regional Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals. 
6. Lead cross-functional Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, as appropriate. 
7. Prepare and communicate regional CMC dossier risk analyses, contingency plans and Lessons Learned documentation on major submissions. 
8. Acting as single point of contact for products in responsibility 
9. Proactively providing strategic input at DRA/TRD/Tech Ops sub team meetings and proactively providing feedback and consequences to the rest of the Reg CMC project/product team, including global coordination/regulatory evaluation of change requests in CHARDAS 
10. Collecting the strategic input from the other Reg CMC Project Managers and coordinating overall global Reg CMC strategy for the product 
11. Responsible for coordination of global CMC submission SWOT 
12. Represent REG CMC at Global Supply Support Teams (SST) 
13. Review and advise on TRD/Tech Ops source documents to be included in registration documentation (i.e. testing monographs, stability protocols and reports) 
14. Preparation of high-quality technical dossiers for worldwide registration of new pharmaceutical products including medical devices
15. Maintenance of the current product portfolio by submission of technical variations & revalidation of existing Marketing Authorizations
16. Support of RA Category organization for all questions concerning technical documents / CTD Module 2 (QOS) & 3 for new Marketing
17. Centralized, MRP, and national procedures
18. Health Authority Meetings with FDA, CHMP, PMDA, NMPA

02.2008 – 06.2009        Novartis Consumer Health SA, Nyon, Switzerland

                                   Regulatory Affairs Officer, CMC and Strategic Growth Market Global Regulatory Affairs 
(short-term assignment responsible for Medicinal products & Nutritional Supplements)

1. Preparation of high-quality technical dossiers for worldwide registration of new products
2. Maintenance of the current product portfolio by submission of technical variations & revalidation of existing Marketing Authorizations
3. Support of RA Category organization for all questions concerning technical documents / CTD Module 2 (QOS) & 3 for new Marketing Authorisations, revalidations and variations including renewals
4. Introduction of new API sources via appropriate variations
5. Regulatory interface to third parties such as manufacturer of finish product as well as API supplier and negotiator to obtain high quality documentation
6. Continuous update of the status of technical documentation to ensure traceability by accurate status recording and proper archiving
7. Responsible for CMC activities for project where range of products are being rebranded and transferred to new manufacturing site
8. Cross functional activities with other departments within and outside Novartis Consumer Health
9. Registration of new marketing authorisation in various countries
10. Ordering of CPP`s and preparation of statements
11. Preparation of documentation as of requirements from SGM markets
12. Preparing answers to questions to local Health authorities

03.2007 – 11.2007        Baxter Biosciences, Neuchatel, Switzerland, (short-term assignment)

                                   Process Technician for the technical manufacturing support department

1. Data compilation and analysis to maintain the production parameters
2. Preparation of protocol & campaign report in collaboration with QA

06.2006 – 09.2006        ExcellGene SA, Monthey, Switzerland

Associate Engineer 

1. Production of monoclonal Antibodies
2. Preparation of protocols and reports
3. Liaison with customers to ensure requirements me

June 2006                   EPFL, Lausanne, Switzerland (Consultancy assignment)

                                   Engineering consultant for the Biotech Laboratory

1. Preparation and maintenance of bench scale reactor

03.2005 – 06.2005        GlaxoSmithKline, London, United Kingdom 

Senior Research Scientist in BPC Pharmaceutical Dev. Department Process

1. Development of production process under GMP requirements 
2. Data reporting

01.2005 – 02.2005        Process Operator (Pilot Plant) in the BPC Pharmaceutical Development Department (short-term assignment)

1. Update of SOPs on production process
2. cGMP compliance & validation of biopharmaceuticals manufacture
3. Creation & maintenance of production process documentation

12.2004 – 01.2005        Cambridge Antibody Technology, Cambridge, UK (short-term assignment)

Research Scientist in the Ophthalmology Biology Department 

1. Maintenance of cell banking

10.2003 – 04.2004        AstraZeneca Biotech Laboratory, Södertälje, Sweden (short-term assignment)

Research Scientist in the cell science team (6 months contract) following 6 months diploma thesis traineeship

1. Development of a protocol for transient expression for toxicity studies 
2. Poster presentation: Cell Culture Engineering IX, Cancún Mexico 2004. Effects of medium supplements on transient gene expression.
3. Development of analytical methods (ELISA, HPLC, …)

1993 – 2003                 Fuchs Gewürze GmbH & Co, Melle, Germany

Production technician & QC 

1. Responsible for ISO standard compliance - spice manufacturing 
2. Part-time job in parallel with education

Education

2011 - 2013                  EUCRAF, Freiburg, Germany 

Postgraduate Master Course "Regulatory Affairs for Biopharmaceuticals including ATMPs.          

2007 - 2009                  ETH, Swiss Federal Institute of Technology, Zürich, Switzerland

Pharmaceutical industry postgraduate courses 

1. Regulatory Affairs: EU, Swiss and US regulations of medicines, regulatory procedures (marketing authorisation procedures, clinical trial application, variations), pharmacovigilance, biologics, generics and biosimilars
2. Quality and GMP: quality assurance and quality control principles, EU authorities /FDA / Swissmedic quality requirements, statistic tools in quality assurance and process management
3. Project management for pharmaceutical industries including case studies
4. Pharmabusiness, Marketing and Communication including case studies
5. Pharmaceutical Development and Production This course provides an introduction and overview of the current technologies and strategies applied in pharmaceutical development and production. In particular, an outline of the development and manufacturing processes is presented, and key current and future oriented technologies are dealt with in more detail. The course also covers organizational aspects such as supply chain management.

1998 - 2004                  FH-Aachen School of Chemical & Biotech Engineering, Jülich, Germany 

1. Biotechnological Engineer Diploma (obtained in July 2004)

1992 – 1997                 Berufliche Schulen of the Hochsauerlandkreis of Olsberg, Germany 

1. Biological Technical Assistant Diploma 

Key Skills

• German (mother tongue), English (fluent), French, Swedish  

1. Very good IT experience: 
   - Microsoft Office including Access, SAP, Maple, Imaging software
   - Minitab statistical software for data analysis
   - Databases: Veeva RIM, Aegis Discoverant, Blue Mountain Calibration Manager, QLP, Metaphase, Isotrain, Documentum based documentation databases (GEMA),                     Trackwise; GPRS, RAPID and other tracking databases, Veeva Vault

Sebastian Baumann is an accomplished professional with over 15 years of experience in the pharmaceutical industry, spanning various roles from research, production, quality assurance, to global regulatory affairs. He holds an Engineering Diploma in biotechnology and possesses a comprehensive understanding of regulatory affairs and compliance across different product categories including Rx and OTC medicine, food supplements, cosmetics, and medical devices.

Baumann began his career as a research scientist at AstraZeneca, gaining experience in GLP and transient expression of mammalian cells. He then moved to GSK, working under cGMP in biopharmaceutical manufacturing. Throughout his career, he held positions at companies such as Baxter Bioscience, Novartis, F. Hoffmann La-Roche Ltd., and Galderma, accumulating extensive regulatory and CMC experiences in small and large molecules, including biosimilars and combination products.

His roles have included Regulatory Affairs Manager, Regulatory Affairs Compliance Leader, Regulatory Affairs Registration Manager, and Global Clinical Supply, IMP Quality Operations. Notable achievements include developing regulatory strategies, managing regulatory submissions, leading cross-functional project teams, and representing companies in interactions with health authorities worldwide.

In his current role as a Regulatory Affairs Manager at Colgate Palmolive, Baumann oversees regulatory registration strategies for EU medicinal drug products and medical devices, ensuring compliance in a complex regulatory environment. He collaborates with internal stakeholders, participates in regional and global regulatory projects, and stays updated on regulatory changes.

Baumann holds key skills such as fluency in multiple languages (German, English, French, Swedish), proficiency in IT tools including Microsoft Office, SAP, and various databases, and a postgraduate Master Course in Regulatory Affairs for Biopharmaceuticals. He is detail-oriented, possesses excellent leadership and communication skills, and thrives in fast-paced, cross-functional environments. Baumann's extensive background makes him a valuable asset for companies seeking expertise in regulatory affairs and compliance.

• Postgraduate Master Course in Regulatory Affairs for Biopharmaceuticals including ATMPs, EUCRAF, Freiburg, Germany, 2011-2013.
• Pharmaceutical industry postgraduate courses, ETH, Swiss Federal Institute of Technology, Zürich, Switzerland, 2007-2009:
  • Regulatory Affairs
  • Quality and GMP
  • Project management for pharmaceutical industries
  • Pharmabusiness, Marketing, and Communication
  • Pharmaceutical Development and Production
• Biotechnological Engineer Diploma, FH-Aachen School of Chemical & Biotech Engineering, Jülich, Germany, obtained in July 2004.
• Biological Technical Assistant Diploma, Berufliche Schulen of the Hochsauerlandkreis of Olsberg, Germany, 1992-1997.