A top 10 global pharmaceutical company is currently recruiting a Regulatory Manager. This organisation develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. This position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the regulatory field.
- 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 the company's Consumer Healthcare 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 the 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 (GRA) 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 to help develop the regulatory strategy or components of filing strategies designed to minimise the 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.
Skills and Requirements:
- Degree in pharmacy, chemistry or life science.
- 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.
- Strong organisational and planning ability to organise and prioritise a high volume of work so as to ensure that all regulatory activities meet business targets.
- Strong customer focus and good team player who has the ability to work with a large group of people.
- An excellent communicator who ensures that marketing expectations are met with ongoing communication.
- Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of a variety of stakeholders and ensuring compliance with regulation.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at 0203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.