Regulatory Affairs Director, CMC ** Global Role (US, EU, China, Japan, LatAm) ** Rare Diseases ** Remote (if based in California)

Reference: TM10595

Expiry Date: 17-08-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
San Francisco County
United States
Remote Working

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Job Description

Location: California / remote / home working

Our client is an exciting and dynamic, California based Biotechnology company with a mix of four modalities and a strong portfolio of development and recently marketed products, all in the rare diseases space.  They are now recruiting for a highly motivated Regulatory CMC professional with 10+ years of drug development experience in a leading role to manage a variety of Biotechnology projects/products marketed globally. 

You will be supporting products (recently) approved in the US and EU, and now you will be leading projects for the 1st wave of the global role out(s) to several (major) countries and regions including Japan, China, LatAm, Canada (and more). You will support and manage global regulatory activities associated with the Chemistry, Manufacturing and Controls for clinical and commercial products and provide input into the product strategy and to the direction provided to commercial and clinical teams.

This is not a departmentalised regulatory CMC department so you will get to have variety and depth in your project decision making and be encouraged to “wear many hats”.  This will be a broad based and varied role where you will have the opportunity to take high levels of responsibility, in a company big enough to have 6 products on the market, but small enough for your voice to be heard, recognised and respected by the CEO.

Experience needed:

  • Extensive CMC regulatory experience with strong scientific background in biologics who maintains abreast of current regulatory intelligence in global markets.
  • CMC regulatory strategy lead for projects in various phases of product life cycle including Global market applications and post market approval line extension studies & LCM.
  • Proven ability to identify and communicate CMC regulatory risks and opportunities to internal and external key stake holders, proactively support the comprehensive stake holder management.

Responsibilities:

  • Lead the development of regulatory strategies and interaction with global Health Authorities; provide strategic input and regulatory advice to the project teams on clinical programs and life cycle management of marketed products.
  • Collaborate with project teams to develop and implement regulatory strategies. Ensure and/or enhance regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle. Proactively identify project CMC issues and implement appropriate regulatory strategies to mitigate risks.
  • Manage the preparation and submission of regulatory applications (IND/CTA, NDA/BLA/MAA, annual reports, etc.) and any post-marketing commitments. Develop and/or review regulatory documents to ensure that all submissions are of high quality. Communicate with internal and external partners to obtain required supporting documents and data for compilation of regulatory submissions in a timely manner that supports agreed upon project timelines.
  • Coordinate the task of drafting responses to CMC related questions from FDA/global health authorities per established process.

On offer is a very competitive package including a high-end basic salary, bonus of 20% and a generous LTi package worth potentially an additional 40% of your yearly basic salary. PTO is generous and healthcare and insurances are all fully comprehensive. This role can be remote, but monthly/occasional travel is required to the HQ, based in San Francisco (close to the airport).

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, on US 908-348-6714. I will support you throughout the interview and on-boarding experience.

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