Regulatory Affairs Director of Policy, EMEA (BE)

Reference: TM140219B2

Expiry Date: 20-10-2019

Categories R & D, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Belgium

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Job Description

 

Location: Brussels

Join a company with a dynamic, innovative and entrepreneurial approach to drug development! We have a unique opportunity with a unique Top 20 Pharmaceutical organisation within their EMEA head office based in Central Europe who are going through a really strong stage of expansion, with a  culture that is still based on individual achievement mixed with team goals. 

My client is very different to other top 20 organizations as they are not departmentalized, or rigid in approach or have grown through buying a number of other companies each year. This organisation has grown and developed by having a dynamic, innovative and entrepreneurial approach to drug development and product registrations, and they want their Snr management team to continue to foster and encourage this approach through regulatory intelligence and policy.

This position is for those who want to shape EMEA policy for an organisation that is at the front of research for its therapy areas in biologicals and small molecules. Reporting into the Global Head of Regulatory Policy and Intelligence, you will be given the support and remit to shape health authority interactions, policy and how this organization innovates with development for the EMA region (main priority Europe but not exclusive). You will become the bridge and go-between for all regulatory policy platforms like EFPIA as well as developing the framework for policy, giving my client a greater voice in industry by identifying opportunities at Member State and regional levels.

This is a hands-on networking role requiring you to work closely with the affiliates, assisting the teams at national and regional level with preparing and attending key health authority and industry meetings, as well as guiding/advising on EU regional policy, draft guidelines, new procedures, and innovating for the patient within the existing disease guidances. In essence for this role it’s important that you have the energy, drive and expertise to make your thoughts heard in a global matrix environment. You are here to add value to an organisation that has already shown huge levels of innovation in its approach to growth, product development and patient centricity for a highly rated product portfolio.

Salary and package levels are exceptional and include a six figure basic salary, fully expensed car with petrol card, LTIs, and bonus and eligibility for private school fees. There is also an extensive re-location package which includes up to 3 months accommodation and support. Non Belgium EU citizens will be eligible to receive a tax reduction package bringing taxes down to early 30’s%.

Responsibilities

  • Act as the expert in forming strong interfaces and conduits between Global, local affiliates and particularly Health Authorities within the region (EMA, CMS/RMS, EU Commission)
  • Establish and maintain strong interfaces with Health Authorities within their region, and develop national and regional teams to liaise effectively
  • Drive and shape company policy and shape the environment to drive patient centric thinking in their region
  • Provide regional expertise into the teams to ensure local HA needs and requirements are understood and included where appropriate

Experience/Technical Requirements:

  • Min 10 years Regulatory Experience working experience in Regulatory Intelligence  and policy or from a drug development/therapy background
  • Proven track record of strategic leadership
  • Expertise in building relationship with both Global & Local Health Authorities
  • Excellent communication and influencing skills

Education: Life Sciences to degree or PhD level

 

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, so please contact Theo Moore in confidence for a discussion on +44 207 801 3384 or email me via theo@advtalent.com.

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