Senior Director, Cmc Regulatory Affairs

Senior Director, CMC Regulatory Affairs

United States, Fully remote

Full-time, Permanent

Summary:

I am currently partnered with a specialist Biotech seeking an experienced and energetic regulatory leader to manage the CMC regulatory group and complete regulatory projects consistent with organizational goals. This individual will be responsible for developing regulatory strategies, planning, drafting, and managing CMC-related global regulatory submissions to meet ambitious timelines.

Primary Responsibilities:

• Provide CMC regulatory review for clinical protocols and investigator brochures.
• Contribute to the development of internal CMC regulatory guidance and working instructions.
• Lead, develop, and implement CMC regulatory strategies and author CTD CMC sections to ensure timely and high-quality global submissions for investigational, market, and post-approval applications.
• Lead regulatory risk assessment, identify key CMC regulatory issues, and implement mitigation activities as needed throughout the product life cycle.
• Collaborate with cross-functional leads and effectively communicate CMC regulatory strategies for the assigned projects.
• Develop regulatory strategies and prepare prompt responses to small molecule CMC regulatory questions, pre-meeting packages, and interactions with Health Authorities as required for the assigned project.
• Ensure appropriate CMC regulatory assessments and actions are taken in response to recalls or product complaints during the product lifecycle for assigned projects.

• Knowledge or experience with regulatory requirements in other regions and familiarity with GMP regulations is a plus.
• Proficiency in authoring complex technical documents, including CTD M2 and M3 sections, and life cycle management.
• 8+ years of experience in regulatory CMC within the pharmaceutical or biopharmaceutical industry.
• In-depth knowledge of ICH requirements and regulatory requirements in the US/EU.
• Excellent oral and written communication skills are essential.
• Detail-oriented, self-motivated, and comfortable handling broad responsibilities in an entrepreneurial, fast-paced environment.
• Proven track record of leading global CTA, NDA/MAA, post-approval preparations, submissions, and subsequent responses to Health Authority queries.
• Bachelor's or Master's degree in scientific disciplines, with a preference for a Master's or PhD.
• Required Skills: