Head of CMC Regulatory Affairs

1 week ago


Santa Clara, California, United States Bayside Solutions Full time

Director, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.

Full-Time Position with Direct Hire

Compensation: Competitive salary

Location: Flexible Hybrid Work Environment

Position Overview:

In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory frameworks that facilitate the clinical advancement and market authorization of our cutting-edge product pipeline.

Key Responsibilities:

  • Formulate comprehensive CMC regulatory strategies to underpin product development and approval workflows.
  • Oversee the drafting and maintenance of CMC documentation for regulatory filings, ensuring adherence to the standards set by health authorities.
  • Serve as the principal regulatory authority within project teams, providing CMC insights for investigational products.
  • Collaborate with cross-functional teams and external stakeholders to ascertain global regulatory demands and uphold submission schedules.
  • Engage with regulatory bodies, including the FDA, to guarantee compliance and facilitate efficient approval pathways.
  • Offer expert guidance on CMC-related initiatives throughout the product lifecycle.
  • Remain abreast of international regulatory developments and convey relevant insights to internal teams.

Qualifications:

  • Advanced degree in a pertinent discipline.
  • Significant experience in pharmaceutical or biotechnology product development and global CMC regulatory affairs.
  • Demonstrated success in managing global submissions and a solid grasp of GMP regulations.
  • Strong collaborative abilities and adeptness at managing multiple projects simultaneously.
  • Exceptional written and verbal communication skills.

Preferred Qualifications:

Experience in CMC Regulatory Affairs, particularly in oncology, small molecule development, and clinical trial processes.



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