Lucy Stendall at CK Group is recruiting for a Regulatory Consultant to join a company in the Pharmaceutical industry at their site based in Tadworth, Surrey on a 12 month contract basis.
Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.
The role will be based at our clients' site in Tadworth, Surrey. Tadworth is a large suburban village in Surrey in the south-east of the Epsom Downs, part of the North Downs.
To obtain, manage and maintain product Marketing Authorisations and Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements. Under the guidance and supervision of line management, to conduct associated regulatory activities for the specified markets, and to contribute to the implementation and leading of projects and building of expertise within the Regulatory Department.
Duties and Responsibilities:
• Represent Regulatory Affairs on product based teams.
• Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate.
• Work with WSR regional strategists to provide country input into Global and European Regulatory Strategies as required.
• Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
• Partner with above-country operational hubs to prepare and collate information needed for contribution to departmental and ad hoc reports.
• Manage and Submit Marketing Authorisation Applications.
• Facilitate meeting of local launch dates by ensuring local approval of documents such as Educational Materials. Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations.
• Manage and Submit MA Variation Applications.
• Prepare agreed Module 1 documents in partnership with above-country operational hubs. Review supporting data and ensure that it complies with local regulatory requirements, agree filing strategy with other business functions as appropriate.
• Prepare agreed Module 2 documents in partnership with above-country operational hubs and WSR strategists and with local medical functions.
• Manage and Submit MA Renewal Applications.
• Manage Clinical Trial Approvals.
• Life sciences or chemistry graduate to honours level or equivalent.
• Masters Degree, Post Graduate Diploma or PhD preferred.
• Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs).
• Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products).
• Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred.
• Computer literacy.
• Excellent written and verbal communication skills.
• Proven strength in analytical thinking.
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 44403 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: 44403
- Posted: 11th January 2019
- Expires: 8th February 2019