Associate Director, Regulatory Affairs Combination Products

Location
Tarrytown, New York
Posted
Mar 20, 2018
Ref
9319BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Leads combination product regulatory activities, including regulatory strategy, device development activities, protocol reviews (e.g., Human Factors Studies, Clinical Bridging Studies) addressing Health Authority (HA) requests and driving HA responses.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Provide regulatory interpretation, position and strategy for combination products and device requirements
• Support all device development and filing activities from a regulatory standpoint for initial device discussions/concepts through life cycle management
• Support combination products regulatory submissions, reviews, approvals and HA interactions as related to INDs, CTAs, BLAs, MAAs (US and EU) and Rest of the World (e.g., Canada, Japan, Switzerland, etc.) regulatory filings and interactions.
• Support development of design control documentation and quality systems for combination products
Education and Experience:
Requires Bachelors in Science, Applied Science, Engineering, Industrial Design, or similar with 7+ year professional experience; Master's Degree with 5+ or PhD with 3+ years professional experience.

Professional Experience should include working with medical or industrial products from a pharmaceutical, regulatory, design, testing, validation, ergonomics and/or human factor perspective. Ideal candidate will have a combination of regulatory, pharmaceutical (large or small molecule), device design/testing, and/or human factors and usability expertise in a regulated environment.

• Experience with/understanding of global regulatory requirements and regulations for devices and combination products is a must
• Regulatory submission experience is a must
• Experience with device development processes for combination products is a must
• Strong Technical writing and oral communication skills are a must, e.g., experience with writing technical documents such as test reports, technical memos, input requirements documents, human factors protocols, and IND, CTA, BLA and MAA combination products' documents

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 9319BR