Senior Manager, Regulatory Affairs CMC

BioMarin Pharmaceutical   •  

San Rafael, CA

Industry: Biotech/Pharma

  •  

8 - 10 years

Posted 299 days ago

This job is no longer available.

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.

Description

RESPONSIBILITIES

With 6 commercial products, 6 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!

As a Senior Manager in Regulatory Affairs, CMC, you’ll be responsible for:

  • Proactively managing Chemistry, Manufacturing & Controls (CMC) aspects of one or more global clinical programs including overseeing preparation and submission of global CMC submissions, including clinical trial and marketing applications; ensure that CMC content is complete and meets all relevant requirements.
  • Evaluating proposed manufacturing changes for global impact to ongoing and existing filings, and providing strategic regulatory guidance for optimal implementation of changes.
  • Researching and interpreting global CMC regulations and provide regulatory guidance to the 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 internal functional groups, contract manufacturing organizations, and corporate partners.

EXPERIENCE

Required Skills:

  • At least 8years 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).
  • Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S. and/or Europe.
  • 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.
  • Proficiency with standard software programs (e.g., Word).

Desired Skills:

  • 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

EDUCATION

BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.  Ph.D. is preferred.