CMC Regulatory Director

Primary Responsibilities:

  • Using strong project management skill, prepares regulatory Chemistry, Manufacturing and Control (CMC) content for global health authorities (IND, IMPD, NDA, MAA), within timelines and in accordance with regulations, and tracks documents, including associated tasks.
    • Leads the development and preparation of CMC-related documents and ensures they meet current regulatory standards, are high quality, consistent, complete, and approvable on the first review cycle. This includes, but may not be limited to, Biological License Application (BLAs), electronic Common Technical Documents (eCTDs), Investigational New Drug applications (INDs), briefing documents, Orphan Drug Applications, and Marketing Authorization Applications (MAAs).
    • Provides regulatory CMC summaries for Annual Reporting requirements.
    • May contribute to non-CMC related documents for IND and BLA submissions.
    • Leads IND maintenance to support clinical development activities.
    • Establishes product specific strategies to ensure successful development of CMC packages to support early development, registration and life cycle management.
    • Manages and participates in post-approval, global product activities. This includes, but may not be limited to, change control, product complaints, supplements and variations leading to labeling updates.
    • Develops timeline for responding to CMC-related inquiries from global regulatory agencies to ensure issues are addressed in a timely manner. Assists in the preparation and review of responses to global health authorities.
    • Participates in regulatory CMC-related health authority meetings and assists with the preparation of meeting packages and summaries/minutes.
    • Reviews and edits technical documents provided by the CMC function and extracts information necessary for regulatory submissions. This may also involve recommending changes to technical documents to ensure conformance with existing regulatory approvals.
    • Remains current on CMC regulatory intelligence including ICH, USP and other guidance.
  • Directs CMC Regulatory strategy development and implementation, providing expertise in CMC Regulatory for all products. Effectively interprets regulatory guidance and provides recommendations to key stakeholders.  Works cross-functionally, representing CMC Regulatory to external service providers and contract manufacturers, as appropriate.
  • Actively collaborates with development teams, Manufacturing, Technical Operations and Quality to develop and execute US regulatory strategies and contingencies for assigned projects during product development, validation and commercialization. Plans and manages CMC Regulatory project activities, including the development and maintenance of budgets and timelines. Ensures adherence to relevant regulatory guidance and regulations, as well as company Standard Operating Procedures (SOPs).  Participates in decision-making and risk-management process.
  • Creates, maintains and executes CMC Regulatory Project plans, timelines, and other tools required to facilitate planning and coordination of deliverables for each assigned Project. Facilitates the development of the integrated CMC Project plans relevant to the CMC Regulatory deliverables and ensures alignment across relevant functions and smooth transitions among pipeline stages.  Facilitates contingency and risk mitigation planning.
  • Interacts with Sr. Management / executive levels. Exercises judgment and exerts some influence on the overall objectives and long-range goals of the CMC Project.  May represent the department in relevant internal/external committees.

Education and Experience:

  • Requires Bachelor’s degree in any physical or Biological Science and at least 7 years of overall industry related experience. 5+ years of related CMC Regulatory experience
  • Advanced degree (M.S. or Ph.D.) a plus
  • PMP certified, MBA and/or experience managing projects a plus

Special knowledge or skills needed and/or licenses or certificates required:

  • Demonstrated, hands-on experience in pharmaceutical development.
  • Experience within a GMP environment with a firm understanding of industry regulations and best practices
  • Excellent working knowledge of the US and EMEA regulations for drugs.
  • Knowledge of global regulatory guidance
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Thorough knowledge of the drug development process, with a focus on IND and New Drug Application (NDA) processes.
  • Demonstrated experience in preparing IND and/or NDA submissions.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

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