Senior Director - CMC Regulatory Affairs Specialist

Posted 12 June 2024
Salary Negotiable
LocationBritish Columbia
Job type Full Time
Discipline CRO & Clinical Operations
Contact NameGeorge Hebden Lee

Job description

Mantell Associates is partnered with biotechnology company who are seeking an experienced and motivated CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs Specialist to join our team at the Senior Director level.

As Senior Director, you will be responsible for ensuring compliance with global regulatory requirements for oncology products, including small molecules and biologics. This role involves working closely with cross-functional teams to prepare and submit regulatory documents, manage regulatory timelines, and provide strategic regulatory guidance throughout the product lifecycle.

Senior Director Regulatory Affairs - Responsibilities:

  • Develop and implement CMC regulatory strategies for oncology products (small molecules and biologics) to ensure successful product registrations and lifecycle management

  • Ensure compliance with global regulatory requirements and guidelines (e.g., FDA, EMA, ICH) for CMC submissions

  • Prepare and review high-quality CMC sections of regulatory submissions, including INDs, NDAs, BLAs, MAAs, and variations/supplements

  • Coordinate and compile CMC documentation, ensuring accuracy, consistency, and compliance with regulatory standards

  • Manage CMC regulatory timelines and deliverables to support project milestones and product development goals

  • Facilitate communication and collaboration between internal teams (e.g., R&D, Quality, Manufacturing) and external stakeholders (e.g., regulatory agencies, contract manufacturing organizations)

  • Monitor and interpret global regulatory guidelines, policies, and trends related to CMC for oncology products

  • Provide regulatory intelligence and strategic guidance to cross-functional teams to inform decision-making and risk management

  • Prepare for and participate in regulatory agency meetings, teleconferences, and inspections related to CMC matters

  • Develop and maintain effective relationships with regulatory agencies and industry associations

  • Support post-approval CMC activities, including change control, regulatory submissions for product changes, and response to regulatory inquiries

  • Ensure continued compliance with regulatory requirements throughout the product lifecycle

Senior Director Regulatory Affairs - Requirements:

  • Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Chemical Engineering)

  • Advanced degree (Master's or PhD) preferred

  • Minimum of 15 years of experience in CMC regulatory affairs, preferably in the oncology field and with both small molecules and biologics

  • Proven track record of successful regulatory submissions and interactions with global health authorities

  • Strong understanding of CMC regulatory requirements and guidelines for oncology products

  • Excellent technical writing and communication skills

  • Ability to manage multiple projects and priorities in a fast-paced environment

  • Detail-oriented with strong organizational and project management skills

  • Ability to work collaboratively with cross-functional teams and external partners

  • Proficiency in regulatory submission systems and software tools

  • Experience with regulatory submissions in major markets (e.g., US, EU, Japan)

  • Knowledge of regulatory requirements for combination products

  • Familiarity with electronic submission standards (e.g., eCTD)

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.