Associate Director CMC Regulatory Affairs

The Associate Director CMC Regulatory Affairs provides leadership for an assigned product portfolio with a focus on ex-US this role you will be responsible for the development and execution of global regulatory strategies for combination products and medical devices mentor Regulatory Affairs staff support cross-functional program teams and development partners and lead ex-US Health Authority activities. This position is ideal for a regulatory leader who thrives in a matrixed international environment and partners closely across programs and regions to bring therapies and devices to patients worldwide.

A Typical Day

• Lead combination product and device global development activities from early phase through submissions and post-market requirements incorporating input from senior management.
• Represent Combination Products Regulatory Affairs (CP RA) at program meetings and independently provide regulatory interpretation positions and strategy for global CP portfolios across initial registrations and post-approval activities.
• Proactively identify program issues and develop regulatory strategies to mitigate risks to filings; find alternative solutions/workarounds and secure interpersonal consensus.
• Critically review and provide strategic feedback on regulatory documents (e.g. IMPDs meeting packages scientific advice MAAs quality defect assessments Notified Body Opinions) to expedite development licensure and market access.
• Lead and facilitate interactions with global regulatory authorities (e.g. meetings responses to information requests inspections).
• Perform review and approval of compliance activities to confirm regulatory impact and device submission requirements for clinical and commercial filings; mentor colleagues through compliance assessments and identify process improvements.
• Present CP RA perspectives at internal and external forums (e.g. department meetings conferences workshops).
• Participate in company working groups and build cross-functional collaboration.
• Develop Working Instructions SOPs and Reviewers Guides to promote consistent efficient practice across CP RA units.
• Identify regulatory gaps in manufacturing and global RA processes advance appropriately and contribute to business efficiency improvements.
• Establish lead and maintain a knowledge base of current and emerging CP regulatory guidelines.
• See opportunities to initiate operational changes and policy modifications.
• Act as a mentor and coach for team members.

This Role Might Be for You If You Have

• Experience supporting combination products through development and approval.
• Strong understanding of global CP RA regulations with particular focus on EU Medical Device Regulation 2017/745.
• Experience engaging with EMA and EU Notified Bodies.
• Experience with device regulatory requirements and development processes for combination products including authoring technical documents (e.g. test reports technical memos input requirements human factors protocols).
• Experience preparing information for CE mark and Notified Body Opinion submissions.
• Critical thinking strong problem-solving and risk mitigation skills.
• Excellent communication negotiation and presentation abilities.
• Consistent track record in building collaboration and partnership across cross-functional teams.

To be consideredyou bring a bachelors degree in a relevant technical or scientific field (advanced degree strongly preferred) a minimum of 10 years of pharmaceutical/biotech or equivalent regulatory experience and at least 5 years of relevant CMC/device experience. You are willing and able to travel internationally as needed to support regulatory meetings inspections and stakeholder engagements.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include health and wellness programs (including medical dental vision life and disability insurance) fitness centers 401(k) company match family support benefits equity awards annual bonuses paid time off and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

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 Companys 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.