Senior Manager, Combination Products, Regulatory Affairs

Tarrytown, NY, United States
Jan 08, 2019
Required Education
Bachelors Degree
Position Type
Full time
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 device development activities, protocols reviews, HA correspondence and submission.

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 device development activates from regulatory standpoint during early phase, development, submissions and post market requirements

• Support development of design control documentation and quality systems for combination products

• Support combination regulatory submissions, including collecting HA feedback, IND, CTA, BLA applications and MAA filings.

• Conduct HA correspondence on combination product topic and lead HA meetings on this topic

Education and Experience:
Requires Bachelors in Science, Applied Science, Engineering, Industrial Design, or similar and 10+ years' experience, Master's Degree with 8+ or PhD with 3+ years working with medical, commercial or industrial products from pharmaceutical, regulatory, design, testing, validation, ergonomics and human factor perspective. Ideal candidate will have a combination of regulatory, pharmaceutical, device design, testing, human factors and usability expertise in regulated environment.

• Expertise with device regulations is necessary

• Strong Technical writing and oral communication skills

• Experience with Health Authorities, V&V protocols and test reports is a plus

• Previous experience with device regulatory requirement and development process for combination products is a plus

• Experience writing technical documents like test reports, technical memos, input requirements documents, human factors protocols, etc.

• Experience preparing information for 51O(k:),BLA, IDE, IP and PMA submissions, especially as relates to human factors, is a plus

• Human Factors and Pharmaceutical experience is a plus

• Regulatory submission experience

• Understanding of global regulatory requirements for device and combination products

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.