Are you a Senior Regulatory Product Manager – next step Global Regulatory Lead (CNS)

Reference: DG261119A

Expiry Date: 26-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Uxbridge
Greater London
United Kingdom

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Job Description

Are you a Senior Regulatory Product Manager – next step Global Regulatory Lead (CNS)

Dear Reader,

We have found that many individuals with a strong track record in product lifecycle management, want to work on more development-lead filings, and find their career expectations are often eclipsed. Also many companies reward GRL roles to individuals who have taken molecules to their first filing in Europe, not to the individuals who do the full lifecycle management, file the LEs, Pediatrics and new dosage forms.  

If this resonates with you, then this role will appeal, because my client specifically has a GRL position open to anyone who has a strong track record in lifecycle management, including LEs (but in a company where the M3 component is done by RA CMC).

We are specifically looking for you if you fit comfortably in this area, and am reaching out to you with an exciting opportunity to step up to the position of a Global Regulatory Leader for an approved neurology product with several studies running worldwide to deliver their final clinical and Paediatric indications! After this you will rotate to a NME.

Reporting to a PL, you will take ownership over the Regulatory strategy of your molecule and work towards the submissions and approvals. In this task you will be supported by a global matrix team and your regulatory sub-team.

You will have oversight for all the global Health Agency meetings and interactions as well as for the timely delivery of global clinical and marketing authorization applications.

You will have the chance to develop wider skills because you will sit with clinical, access and strategic medical and marketing, allowing for close communication and effective decision-making between your stakeholders.

To apply you will most likely have:

  • 7-10 years of experience in Regulatory Affairs for the EU region plus 1 other
  • Filed line extensions in more than 1 region ideally
  • Some experience in HA meetings and a great deal of experience in responding to HA queries
  • Great communication skills and the ability to inspire and motivate your RA sub-team     
  • The desire to venture into something new

Then you will definitely find this vacancy appealing because it provides:

  • International exposure in more than one ICH region
  • Great working environment located in West London
  • Collaboration with world-class experts in the field of Neurology
  • Generous salary and benefits package, incl. car allowance, bonus, as well as a decent, high-performing stock plan
  • Fast track for further international career development

To Apply!

If this sounds like an opportunity you want to explore, then please press the red “Apply for position”, or contact me, Matt, on +44 (0)207 801 3386 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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.

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