Associate Director, CMC Regulatory Affairs

Provides leadership in support of the Regeneron portfolio products assigned and platform initiatives. The candidate will be responsible for leading the development and execution of global regulatory strategies for biologic products and combination products for the product portfolio assigned and perform the duties outlined below.

This role includes mentoring Regulatory Affairs staff, supporting project teams and development partners, and leading Health Authority activities.

In this role, a typical day might include the following :

• Lead CMC / CP product development activities from a regulatory standpoint during early phase, development, market applications, and post market requirements with input from senior management.
• Represent CMC / CP RA at program meetings and independently provide regulatory interpretation, position, and strategy for global CMC / CP portfolios covering initial IND / IMPD submissions, market registrations, and post-approval activities.
• Proactively identify program issues and develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions / work-arounds, obtain buy-in from organization.
• Critically review and provide meaningful and strategic input on regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and / or biologics.
• Lead and facilitate interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).
• Perform final review and approval of the compliance activities of the portfolio to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country specific regulatory guidance documents.

Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management. Identify opportunities for improvement of processes for compliance tasks.

This role may be for you if have :

• Proven track record of supporting biological product through development and approval is a distinct advantage.
• Experience in dealings with FDA and other regulatory authorities.
• Experience with device regulatory requirements and development processes for combination productions including writing technical documents like test reports, technical memos, input requirements, human factors protocols is an advantage.
• Experience preparing information for 510K, IDE, IP and PMA submissions is a plus.

To be considered for this opportunity you must have :

A Bachelor's degree with a minimum of 10 years pharmaceutical / biotech industry experience including a minimum of 5 years of relevant CMC experience

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.

S. law and apply to U.S.-based positions. For roles which will be based in Japan and / or Canada, the salary ranges are shown in accordance with the applicable local law and currency.

If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.

The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$151,800.00 - $247,800.00