Join Us

View all jobs

Manager/Director, CMC Regulatory Affairs

Manager/Director, CMC Regulatory Affairs

We’re seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Team. At RemeGen, our CMC regulatory affairs group is responsible for a portfolio of Biologic development-stage drug candidates as well as biologic commercial drug products. This role requires you to interact across all the development functions of RemeGen, including process development, analytical development, manufacturing, quality control and quality assurance. This role is based at our site at San Francisco and reports into the Head of CMC regulatory affairs.

Responsibilities:

  • Lead the development and implementation of all CMC regulatory strategy to support global development programs, and market applications for biologic products.
  • Build and manage relationships through active partnering with key internal and external cross-functional stakeholders, which include process development, analytical development, manufacturing, quality control and quality assurance.
  • Write and review eCTD submissions, ensure CMC dossiers meeting ICH format and content requirements, as well as specific local requirements of individual countries.
  • Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications.
  • Stay current with regulatory requirements and initiate process improvements as appropriate.
  • Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.

Qualifications:

  • Bachelor's degree in a relevant scientific discipline, advanced degree preferred with minimum 5 years of relevant Biologics development experience in CMC Regulatory Affairs.
  • Experience in Biologics drug development, market applications and commercial lifecycle is required.
  • Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA.
  • Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
  • Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
  • Experience of recent regulatory submissions for injectable products.
  • Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
  • Multiple languages ability is preferred, but not required.
  • Experience in corporate evaluation and provision of CMC regulatory advice to in-licensing and divestment projects.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Apply for job