Regulatory EU Policy Director

ProClinical Ltd
London (Greater)
09 Mar 2018
15 Mar 2018
Contract Type
Full Time
ProClinical is seeking a Regulatory EU Policy Director for a global pharmaceutical company, to be based in London on a contract basis. This position will play a key role in strategy development, coalition development, and regulatory policy analysis. He/she must be able to effectively track and analyse EU regulatory policy issues that could impact the company'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.

Job Responsibilities:

* Execute effective regulatory policy analysis, strategy development, and coalition building to support the company's policy objectives and business goals in and across European markets
* Represent the company on trade association calls and meetings, generate minutes and follow-up and fulfil commitments
* Build relationships with key industry groups, namely EUCOPE and FFPIA and Europa BIO among others, as well as country-specific 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* Lead teams on generation of comments on draft guidance's; proactively provide comments on new regulatory guidance's, including working with coalition groups.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.

Skills and 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 a 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
* Very strong attention-to-detail combined with ability to see big picture and understand business need
* Strong collaborative skills, as this position requires close working relationships with both internal and external stakeholders.
* BA/BS degree in life science
* Law or doctorate degree in applied sciences a plus

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on Phone number removed or upload your CV on our website - URL removed
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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