CK Group are recruiting for a Regulatory Affairs Specialist to join a company in the Pharmaceutical industry at their site based in Leeds on a 12 month contract basis.
Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies - the largest diversified healthcare group in the world with over 100 years of scientific heritage. They employ approximately 500 people in the UK and Ireland. They are committed to delivering great medicines and have introduced a range of innovative treatments that can make an important difference to the lives of patients with serious health conditions such as schizophrenia, hepatitis C, multiple myeloma, HIV/AIDS and diabetes.
Leeds is well connected and one of the principal hubs of the northern motorway network. Additionally, there is an urban motorway network; the radial M621 takes traffic into central Leeds from the M62 and M1.
- Serve as a consultant and technical expert on Regulatory Affairs matters.
- Under little to no supervision: provides assistance in preparation and submission of global regulatory documents.
Responsibilities include to:
- Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities.
- Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
- Guide conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials.
- Define data and information needed for regulatory approvals.
- Develop labelling specifications and approves proposed labelling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- Provide Regulatory Affairs support during internal and external audits.
- Plans schedules for regulatory deliverables on a project and monitors project through completion.
- Assists in the development of best practices for Regulatory Affairs processes.
- Represents Regulatory Affairs on cross-functional project teams.
- Partners with other functions to define and obtain data to assist with regulatory submissions.
To be considered for the role you should have the following skills, knowledge and experience:
- BS with minimum 6 years of experience or equivalent.
- Practical experience with the preparation and submissions for Class II and III medical devices ( EU and USA).
- Substantial experience of US, EU and International Regulations required. Knowledge of International Regulations in China, Japan, Brazil and Russia preferred.
- Knowledge of additive manufacturing technology and associated regulations (Software), advantageous.
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 46283 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Natasha Young
- Phone: 01246 457722
- Reference: 46283
- Posted: 13th August 2019
- Expires: 10th September 2019