Our client, a Global Pharmaceutical Company has opened a new vacancy within their Regulatory Affairs team and are looking to recruit a Regulatory Affairs Executive on a 6 month contract basis to be based at their offices in Middlesex.
- To manage a defined portfolio of products within the GB&I Regulatory Affairs Group to ensure proactive and timely compliance with all UK, Irish and European legislation and ensure that all regulatory activity is planned and geared to support and deliver commercial requirements.
- To identify and communicate regulatory issues which have the potential to affect the competitive impact of company products in the UK and Ireland.
- Provision of an effective regulatory service to allow OTC medicines, medical devices and cosmetic products to be legally sold in UK and Ireland with strong claims which can be supported.
- To ensure all regulatory maintenance activity, pack copy and advertising for the GB&I business is managed to comply with the regulations and relevant company requirements.
- Responsible for ensuring that medicinal, medical device and cosmetic products can be legally sold and supported in compliance with regulations.
- Provide advice, recommendations and support for product claims, copy and labelling.
- Responsible for ensuring that all personnel are given adequate training and guidance in all aspects of regulatory affairs work, and to ensure that all regulatory systems and databases are up to date and effectively managed.
- Ensures quality of both own and submission team work and compliance with regulatory guidelines and process within the required timelines. Responsible for the maintenance activities associated with a defined portfolio, including product renewals, and routine PV activity.
- Sets and resets priorities in rapidly changing circumstances and works with other team members to maintain focus and deliver objectives.
- Creates and maintains good working relationships within the Business and across Global Regulatory functions, as well as other support functions, including factories and GMS teams, Quality, R&D, and with influential external bodies (Trade Associations and professional bodies).
- Leadership of, preparation and review of day to day submissions with full accountability for delivery. May also take accountability for larger projects as part of a broader project plan i.e. line extensions, global strategic projects, system changes etc.
- Contribute to the assessment of new innovation projects and exploratory product development briefs.
- Working with Category Regulatory Representatives, help develop the regulatory strategy or components of filing strategies designed to minimise time for development and regulatory approval and optimise competitive positioning and global opportunities.
- Required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities and lead regulatory interactions.
- Identifies, challenges, develops and implements written procedures (e.g. local SOPs, work instructions), and proactively highlights opportunities for process improvement.
- Responsible for highlighting own training needs and working with his/ her manager to develop a training plan and achieve training goals.
- Degree minimum in any life sciences.
- Relevant experience in Regulatory Affairs, (including OTC regulatory experience), and with an excellent knowledge of European medicinal, medical device and cosmetic regulatory requirements.
- An in-depth knowledge of the PAGB Code of Practice is essential, together with an excellent working knowledge of other advertising Codes and labelling guidelines.
- Previous experience with electronic regulatory submissions and document management systems.
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@srgtalent.com or +441753 589673
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