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• Bachelors Degree in a pharmaceutical or life sciences (or similar)
• Regulatory Experience, medicinal regulatory affairs experience working on OTC/consumer products in at least one geography, especially such as EU or Asia
• Experience developing regulatory strategies
• Experience in regulatory affairs in the category product area – OTC/Consumer skin health products
• Experience with at least one of; medicinal, cosmetic, medical device product regulations as required by the Category supported or significant adjacent experience in NPD, Quality, Medical, Toxicology within a Consumer Healthcare environment
• Experience of working on similar or related products
• Awareness of regulatory processes in at least one geography
• Demonstrated ability to work autonomously
• Global Regulatory Experience
An exciting opportunity has become available for an experienced Regulatory Affairs Manager to join our team based in our Global R&D Hub in Weybridge. Reporting to the Regulatory Affairs Director, you will be responsible for providing regulatory leadership, governance and expertise to a sub-category (Medicated Skin), brand or portfolio of products such that our products are successfully introduced globally. You will build truly collaborative relationships within the sub-category and local operating countries (LOCs) and ensure all regulatory requirements are met for both new innovation and existing products according to GSK values. You may also be required to provide specialist regulatory advice across the Category and Function.
Who we are:
GSK is a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 countries, a network of 89 manufacturing sites and large R&D centres in the UK, USA, Belgium and China.
GSK Consumer Healthcare combines our strong pharmaceutical capabilities in regulatory, medical, drug manufacturing, and healthcare professional access - doctors, dentists, pharmacists - with best in class fast moving consumer goods capabilities - consumer insight, speed to market, brand focus and the ability to effectively partner with retailers. We call this combination of pharmaceutical and fast moving consumer goods capabilities ‘Fast Moving Consumer Healthcare’, and believe we are uniquely placed to become the first and best Fast Moving Consumer Healthcare Company driven by science and values.
To find out more about Working at GSK, click here.
To find out more about GSK Consumer Healthcare, click here.
• Acts as a Business Partner and provides regulatory advice across a brand or subset of products on aspects of drug/cosmetic/devices development and regulatory requirements as appropriate.
• Develop novel regulatory strategies and influences approaches within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams.
• Communicates effectively within the function at all levels and within cross-functional Project Teams.
• Plans, prepares and delivers high quality core files to agreed timelines
• May lead non-product related activities within the function and input cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage.
• May act as GSK representative to external groups on specific task forces within their field of expertise.
• Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Project Team.
• Support the full life cycle of products, including: maintenance activities; Variations, Labelling, Core File updates.
• Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.
We are passionate about what we do and have created an environment where everyone feels valued, is able to develop, contribute to our mission and be proud of what we achieve. We want people who share our values and believe in our mission. Our investment in training, development and learning opportunities will empower you to be the best you can be, and we’ll make sure you have a stimulating and wide-ranging role that will enable you develop your expertise as you create value for us.
APPLICATION CLOSING DATE – 2nd January 2018
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.
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 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
You may apply for this position online by selecting the Apply now button.
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