US Regulatory: Based RTP, NC OR Remote *** RA Manager or Senior Regulatory Manager ** Support complex lifecycle strategies, Line Extensions on mAbs

Reference: MGADV10349A

Expiry Date: 05-12-2019

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Orange County
United States

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Job Description


Location: Based RTP, NC, USA OR Remote 


To apply for this role, you must be willing to either work remotely with regular visits to the HQ, or you can already commute to RTP, Raleigh-Durham, North Carolina, or relocate to RTP, which is offered and well funded by our client, a R&D-based drug development and full bio-/pharmaceutical company.


About this role ...

You will see yourself as being ready to make a career move, this is bonus payment month after all, so to gain further regulatory skills, and work in global teams, in a company with a well-defined, global project team matrix.

This company prides itself on having highly productive teams but they have fun while working and enjoy working with each other.

Due to expansion of their headcount, and internal moves and promotions, we have this new position to join their US Regulatory Team to work on a mAb with several existing and new indications. You will be mentored by experienced Team Leaders and GRLs, who started in a similar position, some in exactly the same role, when this molecule was just being registered for its first label.  

You will have experience of supporting or leading new indications, dosages or for complex INDs, for paediatrics use, but this is just a guide, if you can show good experiences in regulatory project management and now want to stretch your skills, then please consider the points below, and we would be happy to speak with you:

  1. Are you an aspiring and experienced Sr RA Specialist, Regulatory Manager or Senior Manager and would like to join a company where advancement is based on your merit?
  2. Do you want to work in a company where the Global Regulatory Leader pathway is open to you? In a company where several GRLs are home grown? Some starting in the same team you will be joining?
  3. Do you want to work on a successful brand, and help development and commercial then finalise the last major new lifecycle submissions including paediatrics?
  4. Do you want to know, that your next project is most likely to be a mAb? In a company where they are spending around 22% of Turnover on R&D and the majority of the pipeline is biological innovator NMEs?
  5. Are you able to work remotely, or in Research Triangle Park, or relocation to RTP, in North Carolina?


Your Experience & Skills

You will have a minimum of 5 years’ in managing US regional regulatory procedures and a strong understanding of the US pathways. In return, my client offers a strong package, which we have found is more than competitive with many of the companies in upper East Coast, Mid West and elsewhere in the USA. The package comes with health plan, savings plan / match, and a relocation package if required.


To Apply!

To apply for this role, please register on this web site. My team and I would welcome a phone call in private if you would like to explore this role and opportunity, then please contact either myself, Theo Moore, or my colleague Matt Greig, in the London office on +44 (0)20 7801 3384, or at any time during evenings on +44 (0)7918679405.

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