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Senior Manager, CMC Regulatory Affairs, Biologics Lead

4 weeks ago

San Mateo, California, United States Varite Full time
Job Title:

Senior Manager, CMC Regulatory Affairs, Biologics

Job Summary:

We are seeking a highly experienced Senior Manager, CMC Regulatory Affairs, Biologics to join our team at Varite. The successful candidate will be responsible for leading the preparation of Quality sections of regulatory submissions, including INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency questions.

Key Responsibilities:
  • Prepare high-quality CMC regulatory documents in collaboration with other functions.
  • Develop and implement global CMC regulatory strategies for multiple markets simultaneously.
  • Ensure dossiers meet ICH and local regulatory requirements.
  • Liaise with colleagues in Regulatory Affairs, local Affiliates, Regulatory Operations, and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
  • Maintain a current awareness of CMC registration requirements in each of the International regions and communicate key regulatory intelligence to the organization on a timely basis.
Requirements:
  • BA/BS, MS or Ph.D. or equivalent education.
  • Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience.
  • Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products.
  • Biologics experience or drug-device combination product experience would be an advantage.
  • Proven ability to coordinate the preparation of a variety of CMC regulatory documents.
  • Proven strategic thinking skills, with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously.
Preferred Qualifications:
  • Experience with Veeva Vault, including RIM.
  • Global regulatory expertise.
What We Offer:

This role is a great opportunity to develop knowledge of Regulatory Affairs and work in a dynamic team. The successful candidate will have the chance to contribute to global CMC regulatory strategies and develop their skills in a fast-paced environment.