Manager, Regulatory CMC

136566
  • 96000 USD - 118000 USD
  • Fremont, United States
  • Permanent

Job Title: Manager, Regulatory CMC (Chemistry, Manufacturing, and Controls)

Location: San Francisco Bay Area, CA

Company Overview: We are partnered with a pioneering biopharmaceutical company specializing in the development and production of small molecule therapeutic products. With an established portfolio of approved products and a commitment to innovation, we are dedicated to improving patient outcomes and advancing healthcare solutions.

Position Overview: They are seeking a highly skilled and experienced Manager of Regulatory CMC to join there team. This pivotal role involves overseeing regulatory strategies and submissions pertaining to Chemistry, Manufacturing, and Controls for our approved small molecule products. The ideal candidate will have a deep understanding of regulatory guidelines, exceptional leadership capabilities, and a proven track record of success in regulatory affairs within the pharmaceutical industry.

Responsibilities:

  • Develop and execute regulatory strategies for CMC aspects of new product development, lifecycle management, and global submissions for small molecule products.
  • Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, NDAs, BLAs, and variations, ensuring compliance with applicable regulations and guidelines.
  • Collaborate cross-functionally with R&D, manufacturing, quality assurance, and other departments to provide regulatory guidance and support throughout product development stages.
  • Stay abreast of evolving regulatory requirements and proactively assess potential impact on product development strategies and submissions.
  • Serve as the primary point of contact for regulatory agencies, representing the company during interactions and negotiations.

Qualifications:

  • Bachelor's degree in a scientific discipline; advanced degree (MS, PhD, or equivalent) preferred.
  • Minimum 2 years of experience in regulatory affairs within the pharmaceutical industry, specifically focused on CMC for small molecule products.
  • Strong knowledge of global regulatory guidelines and requirements pertaining to small molecule drug development and manufacturing.
  • Proven track record of successful regulatory submissions and approvals.
  • Excellent communication, leadership, and project management skills.
  • Ability to work independently, manage multiple priorities, and thrive in a dynamic, fast-paced environment.

Work Schedule: This position requires 3 days per week on-site at there San Francisco Bay Area location, with flexibility for remote work on the remaining days.

Amit Sekhon Recruiter

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