BioMarin Pharmaceutical
Director, Regulatory CMC
BioMarin Pharmaceutical, San Rafael, California, United States, 94911
Who We Are
BioMarin 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 Development From 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.
Position Overview As a Director in Regulatory Affairs, CMC, you will be responsible/accountable for: Responsibilities related to a Global Regulatory CMC Product Lead in development of global regulatory strategy and preparation of global CMC Regulatory strategy document for assigned commercial and/or clinical product submissions. Proactively managing Chemistry, Manufacturing & Controls (CMC) aspects of BioMarin’s commercial and/or clinical programs; timely preparation and submissions of global regulatory filings including, clinical trial and marketing applications, post-approval variations and license maintenance activities. Conducting a risk-based evaluation of proposed manufacturing changes for regulatory impact to registered information and providing strategic regulatory guidance for optimal implementation of changes. Researching and interpreting global CMC regulations and providing regulatory guidance to Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization. Representing the Regulatory Affairs CMC function on assigned cross-functional project teams within Regulatory, Manufacturing, Sites, Quality. Managing interactions with global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information. Developing excellent relationships with colleagues and cross-functional stakeholders in WWRD and Technical Operations. Providing advice (strategic and tactical) to junior level Reg CMC (if applicable) on key projects. Periodic travel to attend meetings and/or conferences. EXPERIENCE Required Skills: At least 12-15 years of experience in Regulatory Affairs CMC or related discipline in the pharmaceutical or biotechnology industry, preferably with exposure to both development and commercial phases of product lifecycle. Combination products experience desirable. Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the US, EU, Latin America, Eastern European/Middle East, Asia Pacific, Japan markets. Experience in assessing post-marketing changes. Proven ability to lead cross-functional CMC teams on projects and sub-teams. Thorough understanding of relevant CMC drug development regulations and guidelines. Outstanding interpersonal and communication (written and verbal) skills are required. Able to work in a matrix team environment, such as cross-functional groups in Quality and Manufacturing, including contractors, partners, and CROs in the international markets. Desired Skills: US, CA, EU Regulatory CMC experience. Has lead authoring teams for initial submissions through approvals for MAA and Variations. Biologic and Small Molecules experience. Experience with coaching, training and mentoring team members. Proven ability to successfully interact with Regulatory Authorities. Strong background in chemistry, molecular biology, or similar is desirable. A plus: Project management skills are a plus. Device/Combination products experience is a plus. Experience with global dossier and document management system. EDUCATION BA/BS degree in life sciences in chemistry, molecular biology, or similar is required. Advanced degree preferred.
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/Disabled An 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.
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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 Development From 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.
Position Overview As a Director in Regulatory Affairs, CMC, you will be responsible/accountable for: Responsibilities related to a Global Regulatory CMC Product Lead in development of global regulatory strategy and preparation of global CMC Regulatory strategy document for assigned commercial and/or clinical product submissions. Proactively managing Chemistry, Manufacturing & Controls (CMC) aspects of BioMarin’s commercial and/or clinical programs; timely preparation and submissions of global regulatory filings including, clinical trial and marketing applications, post-approval variations and license maintenance activities. Conducting a risk-based evaluation of proposed manufacturing changes for regulatory impact to registered information and providing strategic regulatory guidance for optimal implementation of changes. Researching and interpreting global CMC regulations and providing regulatory guidance to Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization. Representing the Regulatory Affairs CMC function on assigned cross-functional project teams within Regulatory, Manufacturing, Sites, Quality. Managing interactions with global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information. Developing excellent relationships with colleagues and cross-functional stakeholders in WWRD and Technical Operations. Providing advice (strategic and tactical) to junior level Reg CMC (if applicable) on key projects. Periodic travel to attend meetings and/or conferences. EXPERIENCE Required Skills: At least 12-15 years of experience in Regulatory Affairs CMC or related discipline in the pharmaceutical or biotechnology industry, preferably with exposure to both development and commercial phases of product lifecycle. Combination products experience desirable. Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the US, EU, Latin America, Eastern European/Middle East, Asia Pacific, Japan markets. Experience in assessing post-marketing changes. Proven ability to lead cross-functional CMC teams on projects and sub-teams. Thorough understanding of relevant CMC drug development regulations and guidelines. Outstanding interpersonal and communication (written and verbal) skills are required. Able to work in a matrix team environment, such as cross-functional groups in Quality and Manufacturing, including contractors, partners, and CROs in the international markets. Desired Skills: US, CA, EU Regulatory CMC experience. Has lead authoring teams for initial submissions through approvals for MAA and Variations. Biologic and Small Molecules experience. Experience with coaching, training and mentoring team members. Proven ability to successfully interact with Regulatory Authorities. Strong background in chemistry, molecular biology, or similar is desirable. A plus: Project management skills are a plus. Device/Combination products experience is a plus. Experience with global dossier and document management system. EDUCATION BA/BS degree in life sciences in chemistry, molecular biology, or similar is required. Advanced degree preferred.
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/Disabled An 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.
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