Manager, CMC Regulatory Affairs

The candidate will support the development and execution of regulatory strategies for biologic products and combination products for the portfolio assigned

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

• Support CMC/Combination product development activities from a 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 suggest appropriate strategies to mitigate or fix them, translates ambiguity into actional steps. Ensure appropriate communications between IOPS and global RA in a timely manner

• Review the content and format of regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements, scientific advice) to ensure compliance with applicable regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics.

• Participate in global RA meetings and help to develop regulatory strategies to support CMC/CP product development activities. Participation in communications between Global RA and IOPS as needed

• Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings in accordance with country specific regulatory guidance documents. Demonstrate efficient handling of compliance tasks. Assist specialists and colleagues in regulatory assessment of compliance tasks

This role may be for you if have:

• Have good understanding of current CMC/CP RA worldwide regulations.

• Experience in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for biologic products / combination products

• Experience in dealings with FDA and other regulatory authorities is an advantage

• Established strategic thinking and strong problem-solving skills

• Strong communication and negotiation skills

• Ability to build collaboration and teamwork across cross functional teams

• Demonstrated skill in managing multiple priorities.

To be considered for this opportunity you must have:

• A Bachelor's degree with a minimum of 6 years pharmaceutical/biotech industry experience including a minimum of 2-4 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)