- Develop and implement regulatory strategy for registration and reimbursement of new institutional products and for placing on the market of out-of-pocket products, in close collaboration with Market Access, Medical, Sales and Marketing Department and in line with business strategy and regulatory requirements
- Ensure maintenance of in-line products and support new business opportunities
- Influence, monitor and implement new regulations to support business maintenance and growth
- Interface with outside regulatory and reimbursement agencies and trade associations and provide executive management with regulatory strategy
- Management and development of regulatory staff in Central Europe (3 direct reports)
- Development of regulatory strategies for registration and reimbursement approval as per business needs (assessment of formulas, advice on product category, handle tactics and submission timing, verification of label claims, setting mitigation plans, etc.)
- Negotiate with regulatory and reimbursement authorities during the review process to ensure approval in collaboration with Market Access
- Provide regulatory support to commercial division in all areas pertaining to product life-cycle management and new product development and introduction
- Ensure implementation of new regulations within legal deadlines
- Approval of labels, advertising and promo materials ensuring alignment with local regulations, Codes of Conduct, SOPs, etc.
- Utilize technical regulatory skills to propose strategies on complex issues
- Monitor emerging issues and identify solutions
- Develop a network of relevant regulators, key opinion leaders and industry peers to support and influence regulatory environment in alignment with business model.
- Analyse/negotiate documents/positions put together as AN and within Trade Associations for current and upcoming regulations and assess/influence impact for ANI business to be used for local outreach
- Assess and communicate impact of relevant global regulations/standards in local market
- Monitor emerging issues and identify solutions
- Oversee system to ensure that product safety issues and product-associated events are reported as needed
- Represent Regulatory Affairs in product recall and communication process in countries under responsibility
- Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) preferred
- 4-6 years experience in a regulated industry (e.g., medical products, nutritionals).
- 3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Excellent written German and English communication skills
- Highly developed project management skills
- Excellent problem solving skills
- Understanding the business
- Career development with an international company where you can grow the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
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Senior Specialist Regulatory Affairs Central Europe - Baar, Schweiz - Abbott
Beschreibung
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Abbott's Nutrition Division in is looking for a
Senior Specialist Regulatory Affairs Central Europe
to be based in Baar, Switzerland or in Hoofddorp, Netherlands
Purpose of the role
Main responsibilities
Your profile
WORKING AT ABBOTT
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Do you have what it takes? Then send us your application today. We are looking forward to meeting you
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