Senior Associate Regulatory Affairs, Development Programs
Join to apply for the Senior Associate Regulatory Affairs, Development Programs role at BioMarin Pharmaceutical Inc.
Senior Associate Regulatory Affairs, Development Programs
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Join to apply for the Senior Associate Regulatory Affairs, Development Programs role at BioMarin Pharmaceutical Inc.
About BioMarin
BioMarin is a global biotechnology company committed to translating genetic discoveries into new medicines to improve human health. Since 1997, we have specialized in understanding genetic conditions to create transformative medicines, employing various treatment modalities. Our focus on genetics and molecular biology allows us to develop medicines for patients with significant unmet medical needs. We foster an environment of innovation and collaboration, aiming to be first-to-market or to provide substantial benefits over existing therapies. Our pipeline includes diverse candidates in various development stages, characterized by well-understood biology.
Worldwide Research And Development
Our WWRD engine covers all aspects from research to post-market clinical development, supporting the creation of first-in-class and best-in-class therapeutics for genetic diseases. This role supports regulatory affairs for ongoing development and lifecycle activities of approved products, focusing on operational support for strategies in Europe.
Responsibilities
Development Stage Product
* Support planning, preparation, and submission of clinical trials and health authority interactions in Europe and globally.
* Assist with planning, document development, and meetings for EMA interactions.
* Develop and coordinate content for EU regulatory submissions, including Orphan Drug designation and EU MAA Module 1.
* Assist with EU submissions for PRIME, Orphan Drug Designation, and ATMP classification.
* Ensure high-quality content compliant with regulations and guidance.
* Support maintenance of EU CTAs and participate in study execution teams for EU-specific discussions.
* Collaborate with Regulatory Project Management on submission timelines and with Reg Ops for final document QC and archiving.
Commercial Stage Products
* Support post-approval submissions such as variations, MA renewals, and annual reports.
* Assist with regulatory compliance activities, including EMA Policy 0070, EudraCT postings, and sunset clauses.
Qualifications
* BS degree in life sciences or related experience in drug development.
* Experience with health authority submissions and regulatory planning.
* Project management skills and experience managing clinical trial submissions.
* Knowledge of drug development regulations and guidelines.
* Proficiency with standard software; experience with SAVVi is a plus.
Note: The role may include other duties as assigned. We are an Equal Opportunity Employer committed to diversity and inclusion.
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