Senior Director, Regulatory Affairs CMC

About the Role

We're looking for a Senior Director, Regulatory Affairs CMC to help us expand what's possible for patients with serious diseases. Reporting to the VP, Regulatory Affairs CMC, the Senior Director will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function, RA CMC is required to collaborate closely with multiple functions within Insmed and with external CROs/CMOs. A successful candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends.

What You'll Do

In this role, you'll have the opportunity to plan, execute, and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with various teams. You'll also:

• Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug products worldwide with the flexibility for post-approval maintenance and lifecycle management of the marketed products.
• Perform due diligence assessment of potential drug products of small and large molecules.
• Develop plans for the preparation of CMC meetings with the regulatory agencies, and draft and review regulatory documents for CMC meetings with the agencies.
• Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings.
• Keep abreast of all pertinent regulations and guidance documents for pre- and post-approval submissions.
• Communicate regulatory CMC requirements to team members and advise of implications of the regulatory CMC strategies to CMC development plan and activities.
• Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formulation, manufacturing process, and device combination product development at various development stages and product lifecycles.

Who You Are

You must have a Bachelor's degree and 10+ years of pharmaceutical development and regulatory CMC experience supporting both small- and large-molecule products within multinational companies, including experience serving as a Regulatory Affairs CMC product lead. Additionally, you have:

• Experience in the drug substance and drug product development of small and large molecules in terms of manufacturing process development and impurity controls.
• A solid understanding of US, EU, and Japanese regulations for drugs/biologics with the ability to identify the differences in regulations across the regions.
• Proven ability to liaise with Regulatory Agencies in agency interactions and product development meetings.
• Knowledge of scientific principles and regulatory CMC requirements relevant to global drug development and post-market lifecycle support.
• Working knowledge of relevant FDA, EU, ICH, PMDA guidelines, initiatives and regulations governing CMC drug product development.
• Ability to deal with issues of critical importance, provide regulatory strategy/advice and make reasoned decisions on CMC regulatory issues for which they may not be clear or with specific regulatory guidance.
• Proven success with end-to-end project management within RA CMC or relevant experience.
• Strong communication skills with the ability to effectively present ideas and influence others to achieve desired results.
• Ability to read and collate scientific and medical literature.
• Ability to lead others to move internal and external teams towards achieving goals that support Insmed's key strategic objectives.
• Experience operating as a flexible and diplomatic individual; able to effectively deal with ambiguity, problem solve, and work effectively across functions as a team player.

Nice to Have (but not required)

Advanced degree (MS, PhD, or PharmD) strongly preferred.

Where You'll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Travel Requirements

This position involves occasional domestic and/or international travel (approximately 10%).