Associate Director CMC Regulatory Affairs in London

The Associate Director, CMC Regulatory Affairs provides leadership for an assigned product portfolio with a focus on ex-US markets. In 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 Reviewer's 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 considered, you bring a bachelor's 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.