Regulatory Affairs Director, CMC ** Global (US/EU) development role ** Gain Gene Therapy experience **

Reference: JPC620

Expiry Date: 31-10-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Regulatory Affairs Director, CMC  - Remote - provide regulatory strategic support for global activities (IND/CTAs/NDAs/MAAs) – Use your small molecule experience to gain Gene Therapy project experience!

Location: Remote if based in EST or from offices in Boston, MA

Our client is an established and medium-sized global biopharmaceutical company with a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs across a number of interesting therapy areas for over a hundred years. 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 they have an established portfolio sold in over 100 countries worldwide. They have now also added several Gene Therapy indications to their pipeline.

This position is seen as a key role in the continued growth and development of this expanding Global Regulatory CMC team, and you will like this position 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 including China, Japan, Brazil & Canada  
  • You want to join an organization ranked in the top tier for a number of categories including patient-centricity and corporate integrity

With operations on both the East Coast and also in Central Europe, this is a global organization that is offering the opportunity for you to be fully remote if you are based in EST. You will also be joining a company consistently rated by employees (and within the industry) as one of the best places to work, who listen and learn from patients and care partners so that they can bring forward better solutions.

Reporting to the VP/Head of Global Regulatory Affairs CMC you will be responsible for providing regulatory strategic support for global regulatory activities for innovative small molecules and RNA Oligonucleotides from early development through to global commercialization (IND/CTAs/NDAs/BLAs/MAAs) – so this a full project lifecycle role!

Employee Benefits

On offer is a very competitive package at Director grade, including a strong and highly competitive basic salary, bonus, and stock plan and you will 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. You will also have the opportunity to work remotely, or if you prefer, in a Hybrid home/office system.

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