Associate, Regulatory Affairs CMC III (TEMPORARY)Location San Rafael, California Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.
This position focuses on the management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. The role involves working closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings. Expertise with biologics and/or drug/biologic/device products is strongly preferred. This position is also responsible for obtaining and interpreting CMC regulations and guidance and providing regulatory advice to technical operations departments. Strong communication and management skills are required.
planning, preparation, and submission of the CMC sections of marketing applications globally.
Ensure that the sections are accurate, complete, well-written, and meet all relevant country-specific requirements.
Develop excellent relationships with internal functional groups, contract manufacturing organizations, and partners.
Researching and interpreting global CMC regulations and providing regulatory guidance to the Quality, Manufacturing, Process Development
andother functional groups.
Excellent organization skills.
Attention to detail.
Understanding of ICH guidances and CMC regulations.
5+ Years Experience with Bachelor’s degree in chemistry, biology, biochemistry or related field.
Skills and Experience
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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.