Regulatory Affairs CMC Strategist

2 days ago


Agoura Hills, California, United States ACELYRIN, INC. Full time

At ACELYRIN, INC., we prioritize the well-being of our patients and strive to deliver innovative therapies against serious diseases.

Salary:

$240,000 - $290,000 per year

This salary estimate is based on industry standards for a Regulatory Affairs CMC position in the Agoura Hills area, California / South San Francisco, California / Remote locations.

About the Job:

We are seeking a highly skilled Director/Senior Director, Regulatory Affairs CMC to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and executing global regulatory strategies for CMC (Chemistry, Manufacturing, and Controls).

You will work closely with cross-functional teams to ensure that regulatory submissions meet global requirements and are completed within tight timelines. Your expertise in CMC regulations and experience in managing regulatory submissions will be invaluable in this role.

Key Responsibilities:
  • Lead Regulatory Submissions: Independently lead and manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.
  • Manage CMC Content: Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and review this content for conformance with established requirements.
  • Plan and Execute Regulatory Submissions: Plan and execute regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.
  • Represent Regulatory Affairs CMC: Support and/or represent Regulatory Affairs CMC in Health Authority meetings and lead preparation activities for meetings with Health Authorities on CMC-related matters.
Requirements:
  • Education: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
  • Experience: 10+ years Regulatory CMC experience, including experience as an RA CMC product lead, or equivalent industry experience.
  • Skills: Experience with drug development (drug substances or drug products, analytical characterization, process scale-up or regulatory registration) of products is required. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
  • Leadership Skills: Demonstrate leadership, problem-solving ability, flexibility, and values teamwork. Ability to work independently and complete projects with minimal oversight.


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