Director of Regulatory Policy, EU - Central London

Recruiter
inVentiv Health Clinical
Location
London (Greater)
Salary
£1 - £200 000
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
EZ/5929

Director of Regulatory Policy, EU

Central London

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.

Here at INC Research inVentiv Health we are currently recruiting for a Director of Regulatory Policy to work fully embedded with our pharmaceutical sponsor based in central London.

This role can be offered either as a 12 months fixed term or as a freelance contract.

This position will play a key role in strategy development, coalition development, and regulatory policy analysis. You must be able to effectively track and analyse EU regulatory policy issues that could impact our client's approved products, agents in the pipeline, and all associated disease areas. The individual will work cross-functionally especially in collaboration with EU Regulatory Affairs, EU Government Affairs, and EU Market Access.

Responsibilities:

- Execute effective regulatory policy analysis, strategy development, and coalition building to support our client's policy objectives and business goals in and across European markets
- Represent our client on trade association calls and meetings, generate minutes and follow-up and fulfil commitments.
- Build relationships with key industry groups
- Review and assess recently published global regulatory legislation and policies impacting development of treatments for rare diseases, communicate the impact to management and project teams.
- Lead teams on generation of comments on draft guidances; proactively provide comments on new regulatory guidances, including working with coalition groups.
- Monitor developments and predict policy changes in the rare disease space.
- Actively communicate policy priorities, to educate and engage both internal and external stakeholders in building a favourable regulatory policy environment.
- Provide strategic logistical support for managing calendars and designing effective meetings.

Requirements:

- Experience in regulatory policy, government, and/or biopharmaceutical regulatory policy environment, with a focus on EU-global healthcare or pharmaceutical regulatory policy issues;
- Prior biopharmaceutical industry experience strongly preferred, with exposure to orphan drug policy;
- Multiple foreign language skills are plus;
- Significant knowledge of European and national health legislative and regulatory systems;
- Experience in managing relationships with industry trade associations, multi-lateral organizations, non-governmental organizations, and patient advocacy groups and advocating on policies and issues relevant to biopharmaceutical business interests;
- Proven teamwork and collaboration skills, with a demonstrated ability to interact and influence at all levels;
- Detail-oriented, with strong oral and written communications skills.
- Organizational skills
- Communication skills, excellent verbal, written and presentation skills

Application Details:
If you have the required experience for this position and are eligible to work in the UK then please apply below or contact Ellie Zavrelova on ******************

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