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Head of CMC Regulatory Affairs

2 months ago

Santa Clara, California, United States Bayside Solutions Full time

Chief, CMC Regulatory Affairs - Pivotal Opportunity at Bayside Solutions, Inc.

Full-Time Employment with Direct Hire

Compensation: Competitive salary

Location: Dynamic Redwood City, CA - Hybrid Work Environment

Position Overview:

In the role of Chief of CMC Regulatory Affairs, you will be instrumental in formulating and executing regulatory strategies that facilitate the successful clinical advancement and marketing authorization of our groundbreaking pipeline products.

Key Responsibilities:

  • Formulate strategic CMC regulatory plans to bolster product development and approval pathways.
  • Oversee the preparation and maintenance of CMC sections for regulatory submissions, ensuring adherence to health authority standards.
  • Serve as the primary regulatory authority on project teams, providing CMC support for investigational products.
  • Collaborate with internal teams and external partners to pinpoint global regulatory requirements and uphold submission timelines.
  • Engage with regulatory bodies such as the FDA to ensure compliance and facilitate smooth approval processes.
  • Offer guidance on CMC-related activities throughout the product lifecycle.
  • Remain updated on global regulatory trends and convey insights to internal stakeholders.

Qualifications:

  • Advanced degree in a relevant discipline.
  • Extensive experience in pharmaceutical/biotech drug development and global CMC regulatory affairs.
  • Demonstrated success in leading global submissions and a solid grasp of GMP regulations.
  • Strong collaboration skills and the ability to manage multiple projects effectively.
  • Exceptional written and verbal communication skills.

Preferred Qualifications:

Experience in CMC Regulatory Affairs, oncology, small molecule development, and clinical trials.