CK Group is recruiting for a Regulatory Manager to join a company in the pharmaceutical industry at their site based in Brentford on a contract basis for 6 months. The rate of pay is £438.98 per day LTD and £339.28 PAYE.
The Company: Our client is a global healthcare company who take on some of the world's biggest healthcare challenges. They provide health benefits to patients and consumers and have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
The Location: Brentford is located at the confluence of the rivers Brent and Thames. The area is well severed by public transport from central London, Waterloo station and surrounding areas.
The Role: Key Responsibilities:
- 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.- Ensure 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.
- Set and reset priorities in rapidly changing circumstances and works with other team members to maintain focus and deliver objectives.
- Create and maintain 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.
- Leadership of, preparation and review of day to day submissions with full accountability for delivery.
- 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.- Identify, challenge, develop and implement written procedures, 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.
- 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.
For more information or to apply for this position, please contact Julie on 01438 842964 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46702 in all correspondence.