Associate Director - Site CMC

The Associate Director Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes.

• With minimal supervision, lead site-specific post-approval change management activities, including record evaluations and regulatory submissions, ensuring compliance with global requirements.
• Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes.
• With minimal supervision, drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities.
• Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions.
• Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics.
• Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations.
• Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale.
• Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities.
• With minimal supervision, implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact.
• Promote sustainable practices and scalability in site-level regulatory operations.

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred.
• 10+ years of overall biopharmaceutical/device industry experience with 5+ years of relevant pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Strong practical experience with global HA requirements, beyond EU/US.
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
• Analyze issues with attention to detail.
• Ability to assess alternative approaches.
• Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines.
• Able to deal with issues of critical importance with minimal supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management.
• Understands who is responsible for different decisions and escalates as necessary.
• Applies decisions taken by the company.
• Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
• Intentionally promotes an inclusive culture.
• Applies the given prioritization framework with limited support. xcfaprz

Excellent written and oral communication skills required.