Senior Global Regulatory Strategy Lead – Early Dev – Copenhagen, DK

Reference: OLI10568A

Expiry Date: 18-10-2021

Categories Biotech, Pharmacy, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Denmark

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Job Description

Senior Global Regulatory Strategy Lead - Early Dev - Copenhagen, DK

My colleagues and I are recruiting for a Global Regulatory Affairs Director or upper level Associate Director to lead projects in development for an international bio-pharmaceutical company based in Copenhagen, Denmark.

Our client is a European-led, global bio-/pharmaceutical company with a history dating back well over 70 years in CNS & Neurology. The function is led by a very well-known Head, and the team is global, including US and EU, managed by an equally capable Senior Director, with a track record in gaining approvals, this role reports in to this person.

This is a permanent role for an experienced Regulatory Affairs Strategist for development projects in Neurology, leading submissions for novel compounds (NCEs / NBEs) – often with adaptive pathways and multiple indications including rare diseases.

The culture is science based, this role will matrix report into a Dev Lead (PL), naturally, this means the team is R&D focused, with an eye to assisting the commercialization team with novel or RWE or PRO end-points, to gain the right data for both the regulatory approval and market access. Also the company respect work life balance, and are known for working smart. It’s a smaller company so getting stuff done is somewhat easier, and stakeholders are driven on data, not personality.

  • You will be responsible for preparing, leading and implementing regulatory strategy for NMEs in development, cross-functionally representing the Regulatory in the global project teams.
  • You will lead, prepare and submit regulatory submissions through your sub-team for assigned products as well as be responsible for any global Health Authority interactions.
  • You will work on variety of projects and will have high strategic influence on development activities from translation stage to early, as well as late stage drug development.
  • You will notice this is a fairly successful company, that nurtures a team culture of mutual respect and support, decisions are made with a long-term view, and the ‘noise’ of company politics is very low, solutions can be addressed effectively and without fuss.
  • You will be supported to relocate to their Global HQ in Copenhagen, DK – a relocation package is offered for the right candidate based on your personal and family situation.
  • Flexible working hours are available post Covid-19 and the role comes with very competitive salary, company bonus structure and other benefits.

In return, it is essential to have at least 7-12 years of Regulatory Affairs regional or global strategy experience, a strategic mind-set and the ability to create and innovative regulatory strategy.

You will have a proven track record of leading major Health Authority interactions and submissions, in either early development or late phase to filing.

English is the business language in the company.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Matt Greig on +447918679405 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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