My Client a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory EU Strategist on an initial 12 Month...
My Client a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory Regional Strategist on an initial 12 Month contract to be based at either their offices in Surrey.
To be accountable for ensuring Emerging Markets regulatory guidance in order to efficiently and effectively execute compliance activities and/or growth opportunities for assigned projects within the company portfolio and to be accountable for ensuring Emerging Markets contribution to Global Regulatory Strategies and that implementation plans are developed for assigned projects.
- Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, minimise resource demands whilst maximising overall project delivery time and probability of success.
- Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
- Partners 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.
- Participate and EM representative on the virtual global regulatory team (GRT), providing EM regulatory strategy expertise for assigned products
- Accountable for 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
- Accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s)
Education & Skills:
- Previous regulatory experience; Bachelor's degree in life sciences, engineering, or public health i.e. Chemistry, Biology or related discipline
- Ability to lead cross matrix teams across regulatory/medical/safety, etc. to an end goal (i.e. regulatory filing)
- 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, agency negotiation)
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@SRG.co.uk or +441753 589673