Director, Regulatory Affairs international

Location
Tarrytown, NY, United States
Posted
Aug 05, 2019
Ref
16975BR
Required Education
Doctorate/PHD/MD
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:
The Head of Regulatory Affairs International will provide leadership for regulatory filings in international markets outside of the US and EU (most of world markets). The candidate will contribute to and/or lead CTA and MAA submissions activities in these markets.

Responsibilities:
This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of Regeneron's quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams are able to meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements.

Responsibilities include

• Planning, managing and executing global CTA, IMPD and MAA submissions

• Internal communication with key stakeholders across development and CMC

• External communication with international Health Authorities, partner companies and their affiliates, and CROs.

• Monitoring newly published international guidance documents
Requirements:

• Managing and mentoring direct reports and/or junior staff members.

• 8-10 years of industry experience required

• Education: Ph.D., Pharm D. or MD

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.