EU Regulatory Strategist
An internationally renowned pharmaceutical organisation is seeking to hire an EU Regulatory Specialist for their office in the UK. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.
The Regulatory Specialist will be accountable for ensuring EU regulatory guidance in order to efficiently and effectively execute compliance activities and/or growth opportunities for assigned projected. They will also ensure EU contribution to Global Regulatory Strategies and that implementation plans are developed for assigned projects.
- Ensuring regulatory contributions achieve the objectives in the strategy, achieve agreed standards, and minimise resource demands whilst maximising overall project delivery time and probability of success.
- Ensuring regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives, or external threats) are mitigated.
- Partnering with project teams and other customer groups (e.g. Country Regulatory Managers and EU Teams) to ensure required regulatory contributions (line plans, MAA, variations, license renewals etc.) meet business needs and are provided to the project teams, to agreed time, cost, and quality standards.
- Participating and representing the EU on the virtual global regulatory team (GRT), providing EU regulatory strategy expertise for assigned products.
- Delivering the project goals and aligning the regulatory strategy with global and business regional needs.
- Accountable for timely submissions and approvals with commercially attractive labelling across the regions.
- Ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s).
Skills and Requirements:
- Ability to lead cross matrix teams across regulatory/medical/safety, etc. to an end goal (i.e. regulatory filing).
- Knowledge of EU regulations and experience in EU procedures, specifically MRP/DCP procedures.
- Experience in communicating with health authorities.
- Proven record of EU authority submissions (i.e. variations, query responses, and agency negotiation).
- Proven regulatory experience with broad knowledge, experience as Regulatory Lead not required, but advantageous.
- Detailed knowledge and expertise in EU regulations.
- Direct experience and proven track record with EU MRP/DCP submissions, queries, responses, and approvals.
- Direct experience and demonstrated track record in communicating/negotiating with Major Regulatory Authority(ies).
- Experience working in leading highly matrix, global and multi-site environment/teams.
- Track record of supporting various products in different therapeutic areas and at different stages of products life cycle.
- Proven track record of dealing with commercial brand teams; understanding how to deliver regulatory information and strategies audiences outside the regulatory line
- Understanding of core processes and principles in research, development, manufacturing, and marketing
- Demonstrated effective negotiation skills with both internal and external stakeholders.
- Understanding of stakeholder needs including Commercial function, Regulators, and Payers.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Keri Marshall at +44 203 871 8093 or upload your CV on our website - www.proclinical.com.
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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