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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 - Strategic Leadership Opportunity at Bayside Solutions, Inc.

Position Type: Full-Time with Direct Hire

Compensation: Competitive salary offered

Location: Hybrid Work Environment in Redwood City, CA

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 cutting-edge product pipeline.

Key Responsibilities:

  • Formulate comprehensive CMC regulatory strategies to bolster product development and approval pathways.
  • Oversee the creation and maintenance of CMC documentation for regulatory submissions, ensuring adherence to health authority standards.
  • Serve as the principal regulatory authority on project teams, providing CMC expertise for investigational products.
  • Collaborate with internal departments and external collaborators to pinpoint global regulatory requirements and uphold submission schedules.
  • Engage with regulatory bodies, including the FDA, to guarantee compliance and facilitate efficient approval processes.
  • Offer strategic direction on CMC-related initiatives throughout the product lifecycle.
  • Remain updated on global regulatory developments and convey relevant insights to internal stakeholders.

Qualifications:

  • Advanced degree in a pertinent discipline.
  • Significant experience in pharmaceutical or biotech product development and global CMC regulatory affairs.
  • Demonstrated success in leading global submissions and a solid grasp of GMP regulations.
  • Strong collaborative abilities and capacity to manage multiple projects effectively.
  • Exceptional written and verbal communication skills.

Preferred Qualifications:

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