Pipeline Regulatory Affairs Manager (Functional Beverages)
GSK is a science-led global healthcare company. Our innovative medicines, vaccines and consumer health products enable millions of people across the world to do more, feel better and live longer. Join us as an Innovation Pipeline Regulatory Affairs Manager in our Consumer Healthcare Nutrition Division and you can look forward to a worthwhile and fulfilling career. Great emphasis is placed on on-the-job learning and development to help you to thrive in our open and inclusive environment. We also trust and respect our people, and reward their performance.
This position involves:
• Acting as a partner to R&D and commercial teams in the development of new scientific platforms and products for GSK nutrition functional beverage portfolio.
• Leading the execution of regulatory strategies with international colleagues in support of geographic expansion opportunities.
• Contributing to the simplification and improvements in global pipeline stage-gate processes in support of rapid new product launches (speed, quality, accuracy, efficiency of regulatory input).
Other responsibilities include:
• To manage and co-ordinate nutrition category regulatory affairs activities in support of the global functional beverage business growth objectives.
• To guide and support regulatory managers or regulatory consultants in key markets to take a proactive stance influencing local market food regulations, and ensure effective input into international food regulation development.
• To direct and co-ordinate regulatory activities in support of the nutrition category in novel areas of health nutrition.
• To provide effective technical regulatory stewardship for the nutrition category ensuring that the outputs of the innovation programme meet all food safety, compliance and business requirements.
Key Responsibilities:
• Designs, approves and co-ordinates regulatory strategies for functional beverage pipeline projects and novel brands/business as assigned by project management board.
• Takes ownership of all regulatory aspects of the assigned programme, and ensures compliance of the assigned programme.
• Co-ordinates supply of documentation to markets for product notification or registration as appropriate.
• Interprets current and future legislation to enhance potential competitive impact of the nutrition portfolio.
• Develops and maintains excellent working relationships within the Nutrition Business, key functions in R&D, and with influential external bodies as required (trade associations, professional bodies, academia, regulators).
• Provides consultation, review and guidance as required for senior management, R&D, and supply chain technical staff.
• Helps develop global GSK nutrition regulatory standards on issues as required.
• Supports in-market compliance evaluation of all technical aspects of the assigned innovation programme.
• Training / briefing of regulatory network on policies and standards as required.
• Supports in-market regulatory managers in dealing with local enforcement authorities when challenges arise: helps to ensure issue resolution with minimum cost, and avoidance of court action and adverse GSK reputation impact.
• Ensures output is delivered to expected business standards, delivered on time and on budget.
• Identifies resource issues to management, including liaison during resolution.
Business Skills & Competencies:
• Bachelor’s degree in a food related discipline with significant experience working in a nutritional and health claim biased part of the food industry.
• Knowledge of food regulations (EU, International, Codex Alimentarius) and the process by which they are produced and amended.
• Network of external contacts within trade associations, government, regulatory bodies.
• Technical product knowledge, preferably functional beverages.
• Sound working knowledge of marketing and operational environments.
• Understanding of R&D processes and quality systems.
• Demonstrated ability to co-ordinate team and project activity.
• Effective at documenting positions, status and processes.
• Proficient in use of IT and key software/systems.
Behavioural Skills & Competencies:
• Excellent influencing and negotiating skills.
• Ability to manage in a network/matrix.
• Ability to deliver sound judgement in an empowered environment.
• Demonstrated ability to apply sound scientific principles, techniques and decision making in driving their assigned programme.
• Driven to deliver tasks and meet milestones, self-reliant and flexible, with excellent time management skills.
• Creating business solutions.
• Responsible for highlighting own training needs and working with his/ her manager to develop a training plan and achieve training goals.
• Strong record of achievement in previous role/s.
This role will be based in GSK House with international travel as required.
If you want to make a real difference to people’s lives across the globe and your own career prospects in the process please send your CV and covering letter in before the 31st of August 2012.
