Senior Manager CMC Regulatory Affairs

The candidate will be leading the regulatory strategies for biologic products and combination products for the product portfolio assigned.

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

• Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements
• Participate in IOPS cross-functional meetings for program-specific discussions, connect the dots across IOPS, proactively identify CMC/CP regulatory issues and develop appropriate strategies to mitigate or fix them, independently finds alternative solutions, acquires buy-in from organization; Ensure appropriate communications between IOPS and global RA in a timely manner
• Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC/CP prduct development activities. Proactively initiating and managing communications between Global RA and IOPS to ensure they happen in a timely manner
• Critically review and provide strategic feedback on regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSURs, amendments, supplements, scientific advice) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
• Identify strategic points required to be communicated for assigned programs and participating in preparation of challenging communications
• Manage the preparation for interaction with global regulatory authorities (e.g., meetings, IR responses, inspections)
• Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings with country specific regulatory mentorship documents. Mentor colleagues in difficult assessment discussions with SMEs or Senior Management.

• Need to have good understanding of current CMC/CP RA worldwide regulations.
• Proven track record of supporting biological product through development and approval is a distinct advantage
• Experience in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions
• Experience in dealings with FDA and other regulatory authorities
• Established strategic thinking and strong problem-solving skills
• Strong communication and negotiation skills
• Ability to build collaboration and teamwork across cross functional
• teams.

To be considered for this opportunity we are looking for:

Bachelors degree in a relevant technical, scientific discipline required; advanced degree is an advantage and a minimum of 8 years (BS/BA) pharmaceutical/biotech 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)