Associate Director, Regulatory CMC

Location:  London, United Kingdom Category: Regulatory

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Description

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.

The position requires knowledge and experience of biologics and/or pharmaceuticals and preferably gene therapy medicinal products. The incumbent must possess technical expertise in the area of responsibility and demonstrate effective problem solving, strong understanding of global regulatory affairs submissions and management skills and the ability to prioritize multiple tasks.
 
The Regulatory CMC Global Product Lead develops and communicates CMC regulatory strategies that are in alignment with project goals and timelines. This includes formulating the global CMC strategy for the Global Regulatory Plan, with input from regional regulatory representatives and CMC SMEs; preparing CMC documentation to support high quality, right first time global regulatory filings including new MAAs, renewals and post-approval submissions, including liaising with GRT regional representatives and relevant SMEs to draft technical content for CMC submissions from development through commercial to support life-cycle management of biotech products.  
Works closely with the BioMarin International Ltd (BIL) Quality assurance, Quality Control and Manufacturing groups to assure the relevant product and regulatory expectations are met;
(as needed) Manage a small team of regulatory CMC professionals or contract workers in the UK or at the BIL site.  
Lead regulatory CMC support for impact assessment to change control, deviation and cGMP inspection readiness at BioMarin sites.
 
Coordinate and track regulatory commitments related to drug substance and drug product technology transfers.
 
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: 
  • Minimum requirement is for a bachelor’s degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.    
Experience:  
  • Minimum of 10 years of Regulatory Affairs, CMC experience 
  • Proven experience in a leadership role with strong management skills and business acumen 
  • Experience with people management preferred
  • Understanding of drug development, technology transfers and working under accelerated timelines
  • Outstanding interpersonal and communication (written and verbal) skills is required
  • Strong writing and editing skills for technical documentation.
  • Proficient with computer and standard software programs.
  • Able to travel 10%. 

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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