Job Information
Abbott Senior Specialist Regulatory Affairs Central Europe in Baar, Switzerland
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
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)
Main responsibilities
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
Your profile
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
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:
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.
Do you have what it takes? Then send us your application today. We are looking forward to meeting you!
Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
Abbott
- Abbott Jobs