Associate Director, Regulatory CMC (Combination Products/Medical Devices)

Company: BIOMARIN
Location: San Rafael
Posted on: February 2, 2025

Job Description:

Who We AreBioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.About Worldwide Research and DevelopmentFrom research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.The position requires knowledge and experience of combination products and medical devices, including understanding of Human Factors and use of combination products in clinical trials. The incumbent must possess technical expertise in the area of responsibility and demonstrate effective problem solving, strong understanding of global regulatory affairs submissions, management skills, and the ability to prioritize multiple tasks.RESPONSIBILITIESAs an Associate Director in Regulatory Affairs, CMC, focusing on Combination Products and Medical Devices, you will be responsible for:

• Developing and communicating CMC regulatory strategies for combination products/medical devices that are in alignment with project goals and timelines.
• Preparing CMC documentation to support global regulatory filings, including liaising with regional representatives and relevant SMEs to draft technical content for CMC submissions from development through commercial to support life-cycle management.
• The role includes compilation of all necessary documentation for global regulatory submissions.
• Ensure submissions and responses to regulatory questions are of high quality and right first time; that content and format of regulatory submissions comply with applicable regulations and guidance governing the development, licensure and marketing of drugs, biologics and/or gene therapy medicinal products.
• Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.
• Demonstrate initiative and have the ability to work independently and collaboratively in a team structure and in a global organization.EDUCATION AND EXPERIENCE
  • Minimum requirement is for a bachelor's degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.
  • Significant experience with registration of Combination Products/Medical Devices (> 10 years).
  • Knowledge of the regulatory framework for Combination Products/Medical Devices in major markets (expertise in US, EU and Canada is essential).
  • Able to apply strategic experience and solutions to clinic development and marketing authorizations worldwide.We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.Equal Opportunity Employer/Veterans/DisabledAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.In the U.S., the salary range for this position is $149,100 to $223,700 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
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Keywords: BIOMARIN, Yuba City , Associate Director, Regulatory CMC (Combination Products/Medical Devices), Healthcare , San Rafael, California