Head of Regulatory CMC Intelligence & Policy (Global role) ** US East Coast, UK or Switzerland (code USA 220520-3)

Reference: MG10519A

Expiry Date: 22-09-2020

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Mercer County
United States

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Job Description

Head of Regulatory CMC Intelligence & Policy (Global role) ** US East Coast, UK or Switzerland

About My Client

Few biotechnology companies have seen such a steady rise in terms of their turnover or high value assets as my client, whom have doubled in size every 4 years in the last 15.

This organization has developed successful therapeutics in all of the modalities, small and large molecules, oligos, viral vectors, they continue to be at the forefront in terms of registrations of the newer sciences, and have a pipeline which is very novel, they are not unwilling to go after some of the most stubborn disease areas.

This role is a newly created position to build on their existing footprint for CMC sciences, CMC regulatory, both in policy and policy forums.

The role is for an individual who has experience of being part of agency side policy development for CMC or being in a company or association influencing policy from the sponsor side.

Your Background & The Role

The opportunity is to now join my client and bring together their internal experts, map the policy against the topics and lay out a strategic plan to lever their footprint and become a strong player in policy forums and policy initiatives across the pharma and biotech CMC and Regulatory CMC topics.

You will either be:-

  • With an Agency / Regulator in a Pharmaceutical Assessor or a related role, and have taken part in policy drafting or have direct experience in outreach to sponsor side companies and trade associations on new CMC related regulatory guidelines and instruments OR
  • You are currently in a major Trade Association and manage the CMC / RA CMC topics
  • You are working in a similar role with a biotech or pharma and now feel ready to build a new footprint for a company with several successful biotech and small molecule products, each a blockbuster in their own right!

Package & Benefits

Firstly, my client is willing for compelling individuals to buy out stock within reason. Secondly, the role comes with a high-end package including bonus, RSU based stock, and in certain countries a car or car allowance. The company have bandwidth on grading for formidable applicants with a clear track record in shaping CMC and CMC regulatory policy.

Relocation / Location & Covid

US Applicants: this role can be based in one of 3 locations including NE and Southern East Coast locations (incl. Washington DC). There is a decent relocation package if one of these three sites is outside commuting distance and during Covid, you can work from home.

European Applicants: this role can be based in 2 locations in the South East both near and within easy reach of London and Heathrow. Relocation is supported for the UK and Switzerland.

Covid 19: My client has a digital hiring and on-boarding process and can hire / on-board you from home if Covid continues. Afterwards, office working is normal, but this role will require some travel for both internal stakeholder and external association and policy forum meetings.

To Apply!

To apply for this role, please press the red “Apply for position”, or contact either myself, Theo Moore, on 855.505.1382, or my colleague Matt Greig - takes calls on Saturday and Sunday AMs (US and European times) on US 908-332-9157 and UK +44 7918 679 405.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380 or US 908-332-9157.

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