Regional Regulatory Strategist

Regional Regulatory Strategist

12 Month Contract

Remote Working

£570 a day inside IR35 – Umbrella

The Regional Regulatory Strategist provides strategic regulatory expertise for regional projects involving multiple (two or more) Business Units (BUs) within the region. They are responsible for developing and implementing creative regulatory strategies for innovation involving multiple EU markets where central coordination is required.

In this role the individual will build a network of collaborative relationships within the EMEA & LATAM R&D organization, R&D and Commercial teams in the BUs, LOC and Global RA, and Global Safety & Medical (GSM) to ensure delivery of agreed innovation, timely submissions and approvals for central registration, certification or notification procedures, as well as product stewardship activities associated with existing business in the region.

The Regional Regulatory Strategist also has a key role in external engagement and influencing the regulatory environment in the region via involvement in pan-European Industry Associations. They will partner with EU Corporate Affairs to keep EU BUs and Global Regulatory Intelligence and Policy (GRIP) informed of emerging issues, new proposed EU guidance or legislation that could impact GSK’s CH business.

 Key Responsibilities include, but are not limited to:

Innovation:

·      Accountable for development and implementation of effective Regional Regulatory Strategies for regional innovation projects involving multiple EU markets across Business Units. This may include geo-expansion of existing products to other markets/BUs within the region.

·      Accountable for regulatory evaluation of external product opportunities for the region that could be of interest to multiple EU markets/BUs, in collaboration with Business Development, Regional R&D and LOCs - providing detailed Regulatory feasibility assessments and risk analyses to enable technical risk assessment and informed decision-making by EMEA R&D and Commercial Leadership.

·      Leading development/coordination of high quality regulatory dossiers/data packages for regional submissions to external regulatory agencies, in close cooperation with Global RA/CMC, GSM, and Regional Commercial and R&D.

·      Development of core labelling associated with new product innovation

Product Stewardship:

·      Accountable for product stewardship activities for an assigned group of products for one or more therapeutic areas or regulatory classifications requiring central coordination, e.g. EU CP/DCP/MRP Licences, Device Technical Files, Cosmetics PIFs and core labelling updates. For medicinal products this includes leading internal regulatory response teams, ensuring approvals are obtained in a timely manner, and ensuring optimal Regulatory Agency interactions.

·      Leading pivotal maintenance or business continuity projects affecting multiple markets within the region.

·      Ensuring compliance with global, regional and local processes, policies, SOPs and working instructions.

External Influencing:

·      Proactively influencing the regulatory environment based on technical regulatory knowledge and experience - may act as a GSK representative on external industry association committees, key task forces or working groups within key pan-European Industry Associations (e.g. AESGP, Cosmetics Europe, Food Supplements Europe) to drive the GSK agenda and provide creative solutions to Regulatory challenges and issues.

·      Responsible for keeping the EMEA BUs informed of emerging issues, and new proposed EU guidance or legislation that could impact GSK CH business

·      Partnering with EU Corporate Affairs and GRIP to align on external positions and strategies for issue management for pan-EU-specific issues

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

·      BSc Degree in a Pharmaceutical or Life Science 

·      EU Medicines Regulatory background (with Medical Devices experience also being desired).

·      Regulatory experience in a Consumer Health/OTC environment

·      Demonstrated knowledge of EU regulatory procedures and requirements for Medicines and ideally Medical devices

·      Direct experience of managing national and/or regional registration or notification processes

·      Direct experience of communicating with external regulatory agencies, assessing Health Authority requests/questions and leading preparation of cross-functional responses

·      Experience of working flexibly across a portfolio of products, handling multiple project priorities.

·      Proven ability to communicate complex information to a variety of audiences in both verbal and written format, including Commercial and Senior management.  

·      Demonstrated Commercial awareness and ability to act as a strategic business partner

·      Evidence of creative and strategic thinking, analytical and problem-solving skills, and technical writing skills

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