Associate Director, Regulatory Affairs - Basel, Schweiz - Moderna Therapeutics

Moderna Therapeutics

Geprüftes Unternehmen

Basel, Schweiz

vor 3 Tagen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

The Role:

Leads and continues to build the Clinical Trial Application (CTA) regulatory group, responsible for providing effective operational and regulatory support for assigned regulatory clinical trial submissions and maintenance activities, including preparation and submission of regulatory dossiers, and maintenance of regulatory databases and archives.

This role liaises with the Clinical Development Organization, Clinical Research Organizations (CROs), and the Global Regulatory Science (GRS) Country Reg Leads in the successful STA submissions and approvals.

Here's What You'll Do:

Continue to build and lead the team supporting the planning and execution of CTAs within the Regulatory team of Moderna, working closely with Clinical Operations, Therapeutic Areas, GRLs and regional strategists, Country Reg Leads, as well as the assigned CROs.

In partnership with the Digital team, introduce new robust tools for 1) tracking country requirements, 2) tracking and monitoring product CTAs, and 3) developing metrics and KPIs regarding the CTA process.

Support regulatory submission to national HAs world-wise as required: e,g, support to putting together dossiers for submission, coordinating operational activities related to M1 (administrative forms filling in; translations coordination; artworks coordination if required etc.)

Prepare and/or coordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments worldwide.

Responsible for managing regulatory Clinical Trial Applications submission activities for allocated clinical trials directly to Health Authorities or facilitating the CTA submission by local personnel in their specific country.

Liaise with and provide oversight to CRO supporting the CTA submissions and query management.

Accountable for the implementation of the global CTA submission strategy, as well as the quality and extensiveness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.

Ensure that the mandatory regulatory requirements are in place to comply with country-specific requirements for CTAs or other regulatory submissions as required.

Interact with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the agreed regulatory strategy for development medicinal products

Anticipate and bring solutions for potential regulatory risks

Maintain good knowledge of regulatory requirements and guidelines especially European regulations on Clinical trials, or other upcoming regulatory initiatives as assigned (e.g. regulations or guidance on novel product initial registration or life cycle management).

Communicate and educate cross-functional teams on European regulatory requirements and changes in the regulatory landscape.

Participate in process improvement initiatives within GRS or the International HQ as required

Maintain an effective archiving and submissions/approvals tracking records

Here's What You'll Bring to the Table:
Degree in Life Science or related discipline

8+ years of experience in the pharmaceutical industry

7+ years of experience in Regulatory affairs incl. conducting of clinical studies

Solid knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)

Detailed regulatory submission experience and regulatory knowledge of CTR and CTIS

Proven project management experience and leadership skills, some people management experience preferred

Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.

Verified ability to lead multi-functional teams, building strong and productive relationships across an organization.

A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics acr