Regulatory Affairs Director ** CMC ** Remote ** Support Global INDs/CTAs/NDAs/MAAs ** Develop your small molecule experience ** Gain Gene Therapy!

Reference: JPC631

Expiry Date: 30-11-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

The company:

Our client is a highly reputable pharmaceutical company that has been in operation for over 60 years and is currently ranked among the top 40 global pharmaceutical companies. With a robust and innovative pipeline, they are bringing forward transformative therapies to address unmet needs across a number of interesting therapy areas in over 100 countries.

As they continue to grow, they are moving into new modalities and expanding/moving products into new regions. The pipeline is well balanced with over 30 indications in development and have now also added several Gene Therapy programs.

The role:

This role involves managing the Regulatory CMC strategy for late-phase development projects through to the initial NDA/MAA and also for potential 2nd wave submissions to major international expansion countries/regions (such as Japan, China, and Brazil) for products in Oncology and Neurology, which will be rare and Ultra-rare indications and in Gene Therapy.

This will be the right role for you if:

  • You want to work in a Global role that covers US/EU development
  • You want to lead NDA/MAAs for a number of highly rated indications
  • You want to utilize your small molecules experience and also work on Gene Therapy products in early development
  • You want to lead the strategic input for newly approved products to major countries
  • You want to join an organization ranked in the top tier for a number of categories including patient-centricity and corporate integrity.

An ideal candidate will:

  • Have both EU and US experience and enjoy being the lead for these projects
  • Be an established Director of Regulatory CMC with small molecules looking for a new challenge in a Global role
  • Be a strong Regulatory CMC professional, who likes to “jump in” and get involved, sharing the workload with a strong team
  • Be somebody who can plan, author, review and submit high-quality CMC modules of investigational and marketing authorization filings for small molecules
  • Be an individual with the ability to prioritize and respond effectively to program changes; work in a cross-functional team environment and with remote teams; with strong attention to detail and the ability to handle multiple tasks in parallel.

Other experiences needed:

  • 10+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred
  • Ability to deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
  • Experience in leading Module 3 sections for investigational and marketing applications for small molecules in the US and EU, including responding to FDA/EMA requests and any associated regulatory program management.


Remote if based in EST or from offices in Boston, MA.

Employee benefits:

On offer is a very competitive package at Director grade, including a strong and highly competitive basic salary, bonus, and stock. You will also receive a comprehensive benefits package that includes Medical, Dental, Life insurance, short-term disability, long-term disability, discounted childcare, numerous employee discounts, extended parental leave, a generous 401k retirement plan, and over 5 weeks of PTO.

To apply!

If you are interested in applying or hearing more about this role, please contact me, Theo Moore on 587.216.9302 or my colleague Ivan.Nash@AdvTalent on 908.378.8980 to discuss the role and/or your application.