Reference Number: JO-2105-467747
Regulatory Affairs Manager
Job Type: Permanent
Location: Hemel Hempstead
Location: Hemel Hempstead
Salary: Highly competitive + benefits
employment: full time, permanent
Job reference: JO-2105-467747
CPL Life Sciences are collaborating with a niche pharmaceutical company currently undergoing rapid expansion based in Hemel Hempstead. Our client is keen to speak to experienced Regulatory Affairs professionals who have extensive experience with regulations and site transfers as this will be the first project you will be managing in this role.
- Responsible for the planning, preparation, and submission of MA applications in North America, Russia, and Australia/New Zealand and addressing RFI/RTQ Response, post-approval variations (Admin, Quality, Clinical & safety changes), renewals, post-marketing commitment submissions and other ad hoc activities in support of maintaining MAs in the EU, MENA, Africa, Asia, and the UK.
- Supervising our client’s current site transfer project, which involves working along with commercial, logistic, and Business Development departments.
- Coordinate with proposed CMO on regular basis to exchange robust information.
- Identify changes to the manufacturing process, equipment, testing, Upsizing, or downsizing of the batch size as per commercial requirement.
- Responsible for submission, approval, and implementation of site transfer variation (with any additional changes) within the set deadline and rolling out of the change globally.
- Working alongside the commercial department to determine the viability of entering new markets, and the regulatory requirements, timelines, and conditions in these markets.
- Working alongside regulatory colleagues to transfer MAs worldwide back to our client from the current MA holder.
- Reviewing and submitting artwork and labeling changes, including management of third-party artwork house.
- Supervising external pharmacovigilance, medical information 3rd party agent, local translators, trademark providers, publishing, and consular service providers.
- Building and maintaining effective relationships with external clients/partners/ local distributors alongside partner regulatory teams.
- Liaising with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
- Keep up to date with Regulatory Changes
- Ensuring all processes are carried out according to guidelines and standard operating procedures (SOPs).
- Being the contact point for colleagues within the company in terms of all queries concerning the technical documentation and the approval of the product
- Knowledge/experience of submission portals i.e., MHRA Portal & CESP etc.
- Responsible for training of team members.
- Assist in Clinical trial application submission and keep a track of clinical trial progress.
- Bachelor’s degree equivalent or higher qualification within life science
- Right to work in the UK
- Strong knowledge of MHRA regulations
- Strong knowledge of GXP requirements
- Strong knowledge of ICH guidelines
- Knowledge of EU DCP/National and lifecycle maintenance
- Authoring & preparation of regulatory packages and documents for submissions
- Direct, hands-on experience of MA transfers
- Reviewing/annotating and approving artworks and labeling
- Experience with managing a site transfer
- Experience working with regulatory agencies to clarify and resolve regulatory matters
- Change Control, Corrective and Preventive Actions (CAPA) & Deviation procedures.
- Knowledge of EU, Asia, and MENA regulations and post-approval procedures
- Conducting gap analysis and review of dossiers
- Implementing falsified medicines directive
- Creating and authoring SOPs
- Consolidation of dossiers into eCTD