Title:
Regulatory CMC Senior Manager
The company I am working with is a biotechnology in clinical stages with an impressive and growing pipeline for intractable diseases. They are dedicated to developing drugs that target diseases with a basis of genetics with their large portfolio of RNA chemistries. Due to their goals and growth plans, the company is seeking a Senior Manager of Regulatory CMC to add to the team.
Key Responsibilities:
- Develop and execute regulatory CMC strategies for combination products, including drug-device and biologic-device combinations.
- Lead regulatory submissions (INDs, NDAs, ANDAs, 510(k)s, etc.) and interactions with health authorities (FDA, EMA, etc.).
- Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure alignment with regulatory requirements throughout product development.
- Provide expert regulatory guidance on combination product design, development, and manufacturing.
- Evaluate and interpret regulatory guidelines and trends related to combination products, ensuring compliance.
- Prepare and review regulatory documentation, including CMC sections of submissions.
- Manage regulatory agency interactions and respond to inquiries as necessary.
Qualifications:
- Bachelor's degree in a scientific or related field; advanced degree (M.S., Ph.D., or Pharm.D.) preferred.
- 3+ years of experience of regulatory CMC, 5+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry, and a specialization in combination products.
- Proven track record of successful regulatory submissions and interactions with health authorities.
- Strong knowledge of global CMC regulatory requirements and guidelines for combination products.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams.
