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EMEA Regional Regulatory Strategist

GSK
Job LocationWeybridge
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Site Name: UK - Surrey - WeybridgePosted Date: Jun 5 2020Are you interested in a strategic regulatory affairs role We have an exciting opportunity to join a newly-created EMEA Regulatory Strategy team, providing regulatory expertise across a diverse consumer health portfolio for EMEA. We are looking for individuals with a combination of strong technical regulatory experience, strategic thinking and communication skills to work across a highly-matrixed EMEA organisation. We will consider applicants from a number of locations.The Regional Regulatory Strategistprovides strategic regulatory expertise for regional projects involving multiple countries within the region. They are responsible for developing and implementing creative regulatory strategies for innovation on non-Power Brands involving multiple EMEA markets where central coordination is required, and for geographical expansion into new markets in the region.In this role the individual will build a network of collaborative relationships to ensure delivery of agreed innovation, as well as maintenance activities associated with existing business for non-Power Brands 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 and representation at pan-European Industry Associations.Key responsibilities;Innovation:

  • Accountable for development and implementation of effective Regional Regulatory Strategies for regional innovation projects on non-Power Brands involving multiple EMEA markets. This includes geo-expansion of existing products to other markets within the region
  • Accountable for regulatory evaluation of external product opportunities for the region that could be of interest to multiple EMEA markets, 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 Central RA/CMC, GCMA, and Regional Commercial and R&D.
    • Product Stewardship:
  • Accountable for maintenance & lifecycle 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 for local stars/drive profit brands. 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 Regional Regulatory Area Leads, LOCs, EMEA R&D and Commercial team informed of emerging issues, and new proposed EU guidance or legislation that will affect GSK CH business
  • Partnering with EMEA CGA and Global Regulatory to align on external positions and strategies for issue management for pan-EU/EMEA-specific issues.
    • Closing Date for Applications: June 12th 2020 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.<i>During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact. This will help us to understand any modifications we may need to make to support you throughout our selection process. </i>*LI-GSKRequired Qualifications and experience:
  • BSc Degree in a Pharmaceutical or Life Science
  • Regulatory experience in a Consumer Health/OTC environment
  • Demonstrated knowledge of EU regulatory procedures and requirements for at least two of the following: Medicines, Medical devices, Cosmetics or Foods
  • 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
    • Company Details: GlaxoSmithKline is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. We discover, make and market life-enhancing products that are used by millions of people around the world, helping them to do more, feel better and live longer. We have 3 primary areas of business in pharmaceuticals, vaccines and consumer healthcare. We have offices in more than 115 countries, major research centers in the UK, USA, Spain, Belgium and China and an extensive manufacturing network with 87 sites globally. Our three strategic priorities are to grow a diversified global

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