An internationally leading pharmaceutical company is seeking to recruit a Regional Strategist to their office in the UK. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer, and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.
- Ensuring EM regulatory guidance in order to efficiently and effectively execute compliance activities and/or growth opportunities for assigned project(s) within the company portfolio.
- Ensuring EM contribution to Global Regulatory Strategies and that implementation plans are developed for assigned project/s.
- Ensuring regulatory contributions, achieving the objectives in the strategy, achieving agreed standards, and minimising resource demands whilst maximising overall project delivery time and probability of success.
- Ensuring regulatory plans are monitored, progress/variance is communicated to Senior Management, and that any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
- Partnering with project teams and other customer groups (e.g. Country Regulatory Managers and EM 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 EM representative on the virtual global regulatory team (GRT), providing EM 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:
- Bachelor's degree in life sciences, engineering, or public health i.e. Chemistry, Biology or related discipline; An Advanced degree in life-sciences, engineering, or public health i.e. PharmD, an MS, or a PhD in biological/chemistry science or related discipline is preferred.
- Knowledge of EM regulations and experience in EM procedures.
- Experience in communicating with health authorities.
- Proven record of EM authority submissions (i.e. variations, query responses, or agency negotiation).
- Knowledge of EU regulations and experience in EU procedures.
- Proven regulatory experience with broad knowledge; experience as Regulatory Lead not required, but advantageous.
- Direct experience and proven track record with submissions in EM, 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.
- A track record of supporting various products in different therapeutic areas and at different stages of products life cycle.
- A proven track record of dealing with commercial brand teams; an understanding of how to deliver regulatory information and strategies audiences outside the regulatory line.
- An understanding of core processes and principles in research, development, manufacturing, and marketing.
- An 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 Emily Oakley-Keenan at +44 2038542469 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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