Regulatory Affairs Global CMC role - Associate Director Grade - US, EU, AsiaPac & LatAm - Cambridge MA (code USA 280921-3)

Reference: TM200421A2

Expiry Date: 28-11-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Regulatory Affairs Global CMC role - Associate Director Grade - US, EU, AsiaPac & LatAm - Cambridge MA

  • Strategic Global role for development products before leading Global submissions
  • Working on small molecules but gain biotech experience in the future
  • Have the platform/opportunity to lead a team and/or people manage 

Location: based in Cambridge/Boston, Massachusetts

This is a rare opportunity where you can grow and develop to be the lead for both US and EU markets, for initially small molecules and then large molecules in a medium sized organization with a structure that likes to give regulatory staff  the opportunity to reach their potential.

This role is focused on taking the lead for strategic development activities initially in the US and EU but with responsibility to lead submissions in all major international regions and territories for a combination product in Phase 3, with the global NDA/MAA planned for 2022.

This rapidly expanding organization has a reputation for giving opportunities to those who show promise and ambition and it’s a fast paced environment where you stand a greater chance of being noticed for your contribution than in a larger organization where you can easily become pigeon holed.   You can easily interact with upper management and expect to be given the opportunity to be involved in multiple regions as the strategic lead in a role where there will be  many challenges for your to grow and gain more experience.

The regulatory department here is part of the Global RA department, so expect to be involved in key strategic decisions for all major markets. You will be encouraged to become a strong performer, and as a result you will receive fast promotions and regular pay increases.

The culture based around creating an environment where people work well together, where people feel empowered to be a success and where people are moving in the direction that they most enjoy! The focus here is on better team work and co-operation with a focus on getting work done and less politics.

In the short-term you will be working on a phase 3 to NDA/MAA and then next wave of major global submissions. In the longer term you will have the opportunity to gain experience in Biologicals and team lead and/or people manage,

The package for this role is extremely generous and includes a top level salary, bonus of up to 20% per annum, yearly stock options and a very likeable benefits and healthcare package.

For compelling candidates a relocation package is available.

To Apply!

To apply for this role, please hit the Apply button or contact Theo Moore on US toll free 855.505.1382 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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