Director CMC Regulatory Affairs

Role Summary

Leads the Chemistry, Manufacturing, and Controls (CMC) & Combination Products (CP) Internal Medicine team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams and development partners, and leading activities with the Health Authority.

Responsibilities

• Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and operational direction for the assigned portfolio, including initial clinical registrations, market application approvals, and post-approval lifecycle management.
• Lead the preparation, review, and submission of regulatory documents to regulatory authorities.
• Provide scientific and regulatory inputs for the assigned portfolio to facilitate and expedite the development and marketing of drugs and/or biologics.
• Oversee and direct interactions with global regulatory authorities, including meetings, information request responses, and inspections.
• Direct and provide advice on the compliance activities for the assigned portfolio, evaluating regulatory impacts and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific guidelines.
• Develop and implement department objectives and work plans, delegate responsibility effectively, and prioritize team workloads to meet organizational goals.
• Provide leadership by contributing to departmental strategy, organizational goals, and policy development.
• Guide team members to address complex and unprecedented program challenges, ensuring timely resolution.
• Participate in cross-functional groups and working groups to improve current practices and establish new processes/procedures.

Qualifications

• Required: A bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including at least 8 years of relevant CMC experience; or a master’s degree with 8+ years of experience; or a PhD with 3+ years of experience.
• Required: At least 3 years of applicable managerial experience.
• Preferred: Proven track record of supporting biological products and/or small molecule drugs through development and approval.
• Preferred: Strong understanding of current CMC / CP worldwide regulations.
• Preferred: Successful leadership in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND), and post-approval submissions for biological products, combination products, and/or small molecule drugs.
• Preferred: Previous experience with device regulatory requirements and development processes for combination products.
• Preferred: Human Factors experience.
• Preferred: Experience in dealings with the FDA and other regulatory authorities.