Associate Director - Regulatory Affairs CMC

This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the daily regulatory CMC activities of assigned projects for development and/or commercial products. These activities include acting as a regulatory CMC representative on cross-functions teams, planning regulatory CMC submission strategies, and conducting regulatory CMC intelligence activities.

• The Associate Director, Regulatory Affairs CMC will be responsible for leading regulatory CMC activities for Anagram’s portfolio of products, through all stages.
• Assist with developing Regulatory-CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities.
• Prepare CMC regulatory documents in support of Investigational New Drug Applications/Amendments (INDs), Biologics License Applications (BLAs), Investigational Medicinal Product Dossiers (IMPDs), and Clinical Trial Applications (CTAs).
• Regulatory Affairs CMC representative on project teams ; provide guidance and communicate regulatory risks and/or mitigations.
• Support development of regulatory processes and procedures to support CMC components of regulatory submissions (ie. assessment of manufacturing change controls)
• Review CMC source documentation in support of dossiers.
• Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines.
• Ensures high-quality and on-time submissions, for INDs, IMPDs, CTAs, Comparability protocols and BLAs that align with company strategies and Health Authority requirements. This includes planning, writing, coordinating, and tracking the CMC dossier towards submission milestones - interacting with cross-functional departments to ensure deliverables are met according to the corporate goals.
• Support regulatory inspections and audits
• Navigate the complex regulatory landscape, staying up-to-date with evolving requirements.

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• A minimum of 8+ years of experience with 5+ years of experience in Regulatory Affairs CMC within the biotech or pharmaceutical industry, along with broad-based CMC technical and product experience
• Expertise in Regulatory CMC requirements throughout the product lifecycle
• Experience with INDs, and NDA’s/BLAs
• Strong knowledge of GMP and FDA and ICH regulations.
• Demonstrated success with leading Module 3 through finalization
• Strong leadership and team management skills.
• Outstanding communication and interpersonal abilities.
• Ability to thrive in a fast-paced, dynamic environment.
• Strong problem-solving capabilities.

• Fast-paced environment – Thriving in an environment of change and continuous improvement is a core competency for all members of our team.
• Dynamic roles
  - We are a small and tight-knit team enthusiastically tackling difficult problems. All team members are expected to contribute to company protocols, provide feedback and to generally think critically about our processes.
• High expectations
  - We have big goals for the future. We expect dedication and positive collaboration from all our team to achieve them.