Regulatory Affairs Snr Manager or AD *** RTP/Remote ***US Liaison and GRL roles open *** P2 to BLA (NC)

Reference: BCT2707A

Expiry Date: 03-11-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Durham County
Съединени щати
Remote Working

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Job Description

“With over 20 indications in their pipeline there are lots of options if you favor a certain stage of development, but with the idea that all roads lead to you managing your own BLA’s and/or moving into a GRL or Therapeutic Lead role.”

Location: RTP, NC but with options for Remote or Hybrid with 2-3 days in the office.

My client is a medium sized global Bio/Pharmaceutical company with a great development pipeline (20 NME’s) and an impressive number of recently approved products across their core therapeutic areas of Immunology and Neurosciences. They are well known for offering a dynamic and highly strategic regulatory working environment and they have a friendly culture where there are multiple career pathways/options available as a next step.

As a Regulatory Affairs Snr Manager or Associate Director, you will be a Regulatory Strategy Lead for indications entering Phase 2 or 3 working cross-functionally with colleagues in the US and EU to inform and influence and ensuring effective liaison across the organization to optimize regulatory strategies. There are also potentially options to work in early development across the portfolio, to focus on projects in Phases 1/2 – but with over 20 indications still in development there are lots of options if you favor a certain stage of development.

In the short-term you will be given the opportunity to focus on your strengths and areas of high interest whilst also working on projects that also fill in any gaps in your development experience. The idea/culture at this organisation is to have their regulatory professionals experienced across the full development lifecycle, who can successfully navigate a BLA or move from a US liaison role to a GRL role.

In the longer term as you gain more achievements you will have the opportunity to be involved in new projects and regions and people management or operating as a Therapeutic Lead, the options here are varied and matched to your own ambitions and career goals.

The salary for this role is considered as strong and the benefits package is comprehensive and includes full medical and healthcare, high level pension contribution from the employer, dental, a great holiday allowance, flexible working hours and options to work from home.

For this position you will need the ability to work well within a matrix environment, build team relationships and interface in a global team environment and have experience of working on projects in either early or late-stage development.

If you are interested in this position, in the first instance please contact Theo Moore on US +1-908.348.6714 or via email at and I would be happy to discuss the role further and give you more information.

If this role isn’t quite for you but you are open to something new, I would welcome to discuss other roles we have open.


To Apply!

To apply for this role, please contact me Theo Moore on US 908.348.6714 or press the red “Apply for position” button. I will support you throughout the interview and on-boarding process!

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