Senior Manager, Regulatory Affairs, CMCLocation San Rafael, California Apply
Senior Manager, Regulatory Affairs CMC
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
With7 commercial products and counting, a rich pipeline of mid- to late-stage development candidates and a personal connection to our patients, BioMarin is the recognized industry leader in rare disease development. This is an exciting time to join BioMarin and to contribute to the exciting portfolio of products. Come work in an entrepreneurial environment where you’ll have the resources and infrastructure combined with visibility and opportunity to tangibly impact patient’s lives and the future of our company. This is your chance to be part of something amazing!
As a Senior Manager in Regulatory Affairs, CMC, will be responsible/accountable for:
- 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 variationsand 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 provide 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.
- 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.
- At least 5 years of experience in Regulatory Affairs 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 and ROW 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 is required.
- Able to work in a matrix team environment, such as cross-functional groups in Quality and Manufacturing, and including contractors, partners, and CRO’s in the international markets.
- Project management skills are a plus.
- 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
BA/BS degree in life sciences in chemistry, molecular biology, or similar is required.Advanced degree preferred.