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Head of CMC Regulatory Affairs

3 months ago

Canada Servier Group Full time

Overview

As a pivotal member of our organization, the Head of CMC Regulatory Affairs will play a crucial role in steering regulatory strategies for our biotechnology products. This position is essential for ensuring compliance and facilitating the development of our innovative therapies aimed at addressing significant unmet medical needs.

Role Overview

The individual in this role will be responsible for orchestrating regulatory activities related to the development, modifications, and international submissions of Marketing Authorization Applications (MAAs) and Biologics License Applications (BLAs). Collaborating closely with key stakeholders, you will define the CMC regulatory framework and work in tandem with pharmaceutical development and manufacturing teams to assess regulatory impacts associated with technology transfers, scale-ups, and method alterations. You will oversee the Module 3 (Quality) of our Marketing Authorizations for biologics.

Key Responsibilities

  • Formulate and implement comprehensive, risk-based global regulatory CMC strategies for both investigational and marketed products, actively influencing product development and lifecycle management.
  • Manage the regulatory CMC components of projects, including the preparation and submission of CMC sections for clinical trial applications (e.g., IND/IMPD/CTA submissions), annual reports, and marketing applications across various regions (e.g., US, EU, China, Brazil).
  • Oversee lifecycle management activities, including variations in the EU, CBE, PAS, and renewal applications at an international level.
  • Represent Regulatory Affairs CMC in global cross-functional teams, including Manufacturing, Quality, CMC/MSAT, Supply Chain, and Product Strategy.
  • Lead the preparation of CMC documentation in response to inquiries from Health Authorities or Agencies, including briefing materials for Scientific Advice meetings.
  • Engage in specific quality and regulatory tasks, such as:
    • Management of Out Of Specification (OOS) issues for stability batches.
    • Monitoring CMC commitments for assigned products.
    • Reviewing Product Quality Review (PQR) documents and conducting regulatory assessments of PQRs.
    • Contributing to Change Control procedures and regulatory impact analyses.
    • Ensuring compliance with the Quality Manual and Quality System of the organization.
    • Verifying that documents adhere to regulatory standards and quality requirements.

Qualifications and Skills

  • A degree in a relevant scientific discipline (e.g., biotechnology, biology, pharmacy) is required, along with over 10 years of experience in CMC/Regulatory CMC within the pharmaceutical industry. An MS or PhD is preferred.
  • Proven experience in preparing and overseeing CMC submissions (INDs, IMPDs, NDAs, and/or MAAs).
  • In-depth knowledge of eCTD elements, structure, and content, with expertise in Module 3.
  • Strong background in CMC product development and collaborative work within cross-functional teams.
  • Exceptional regulatory strategic insight and adaptability in a dynamic environment.
  • Excellent analytical and problem-solving capabilities.
  • Highly organized, detail-oriented, and scientifically driven.
  • Strong verbal and written communication skills, with a keen attention to detail.
  • Familiarity with US, EU, and key international regulatory guidelines.
  • Proficient in working with global teams, managing multiple priorities, and maintaining professionalism.

Travel and Location

  • Minimal travel is expected (less than 20%).
  • This position is based in the USA, with remote options available for the east coast.

Commitment to Diversity

Our organization is dedicated to promoting diversity, equity, and inclusion within the industry. We strive to create an environment that ensures equitable treatment for all individuals and welcome applicants who are passionate and innovative.

Compensation

The salary range for this position is competitive and will be determined based on various factors, including education, qualifications, experience, and organizational needs. Additional benefits include participation in incentive programs and a comprehensive benefits package.