Director, Regulatory Affairs CMC

Salary depends on experience
Posted on 02/21/18
5 - 7 years experience
Biotech/Pharma
Salary depends on experience
Posted on 02/21/18

Description

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. 

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives.

With 6 commercial products, and more in the pipeline and over half a billion dollars of revenue, a global footprint in 40 countries, and a personal connection to our patients, BioMarin is the recognized industry leader in rare disease development. Come work in an entrepreneurial environment where you’ll have the resources and infrastructure combined with visibility and opportunity to tangibly impact patent’s lives and the future of our company. This is your chance to be part of something amazing!

If you’re a dynamic Regulatory Affairs Associate Director/Director with deep knowledge in CMC along with commercial experience with a licensed biologic approved product we want to talk to you. 

You’ll be responsible for:

  • Proactively managing CMC aspects of one or more global commercial programs including overseeing preparation and submission of global CMC submissions, including marketing and clinical trial applications. 
  • Ensuring that CMC content is complete, well-written, and meets all relevant requirements. 
  • Evaluating proposed manufacturing changes for global impact to ongoing and existing filings, and provides strategic regulatory guidance for optimal implementation of changes. 
  • Researching and interpreting global CMC regulations and, providing regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups.
  • Representing the Regulatory Affairs CMC function on assigned cross-functional project teams.
  • Managing interactions with FDA and other global regulatory authorities for assigned project 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 internal functional groups, contract manufacturing organizations, and corporate partners.

Education:

  • BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.  Advanced degree is a plus.

Experience:

  • 6-8years of experience in Regulatory Affairs in a global pharmaceutical and/or biotechnology company with expertise in biologics and deep experience in commercial product lifecycle as well as Phase 1-3.  Experience with commercial small molecules may also be considered.
  • At least 2 years of previous supervisory experience managing associates is required.
  • Thorough understanding of relevant drug development regulations and guidelines is essential.
  • Prior success filing marketing applications, supplements, and variations for biologic products within timelines is required; global submission experiencedesired.
  • Experience in assessing post-approval changes is required.
  • Demonstrated ability to coach, train and mentor teams.
  • 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%.

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