Job Title:
Associate Director/Director, Regulatory CMC
About Us:
BioMarin is a global leader in delivering innovative therapeutics that address rare genetic diseases with significant unmet medical needs.
Key Responsibilities:
* Act as primary regulatory CMC contact at BIL site for end-to-end biological manufacturing.
* Collaborate with Quality Assurance, Quality Control, and Manufacturing groups to ensure product and regulatory expectations are met.
* Manage a small team of regulatory CMC professionals and represent the BIL regulatory team at global meetings.
* Lead global marketing authorizations, renewals, and post-approval changes for biological products.
* Compile documentation for global regulatory submissions and ensure high-quality content and format compliance.
Requirements:
* Bachelor's degree in Pharmacy, Biology, Chemistry, or Molecular Biology.
* Minimum 8 years of Regulatory Affairs, CMC experience, with leadership role and management skills.
* Understanding of drug development, technology transfers, and accelerated timelines.
* Excellent interpersonal and communication skills, with strong writing and editing abilities.
* Proficient in computer software programs and ability to travel up to 10%.
Estimated Salary:
$120,000 - $180,000 per year, based on location and experience.