My client are a UK based Biotechnology company that have been established since 2003. They have a strong portfolio of products in Oncology and CNS in both pre-clinical and clinical development stages. They are looking for a Regulatory Affairs and Pharmacovigilance Manager to join their team based in Wokingham, UK.
This Regulatory Affairs and Pharmacovigilance Manager job is a full time on site position based in Wokingham. The main focus of the role will be regulatory affairs with an 80:20 split to pharmacovigilance activities. As the Regulatory Affairs Manager you will be required to manage the regulatory requirements of early stage clinical trials in both the EU and US. Pharmacovigilance activities will include liaising with pharmacovigilance service providers to ensure safety reporting activities related to clinical trials and marketed products are conducted to internal SOPs.
- Preparation, submissions and maintenance of CTAs and INDs.
- Maintain a regulatory overview of the commercial product.
- Provide regulatory advice, guidance and expertise to the development teams.
- Ensure routine regulatory activities are completed to a high standard.
- Management of regulatory contractors and consultants.
- Prepare, update and train colleagues on regulatory SOPs and procedures.
- Management of pharmacovigilance activities for clinical trails.
- Reconciliation of case reports between marketing partners.
- Management of periodic reporting for the approved product.
- Management of pharmacovigilance contractors and service personnel.
The ideal candidate for this Regulatory Affairs and Pharmacovigilance position will have the following skills and experience:
- Life sciences degree.
- Strong working experience within regulatory affairs.
- Practical experience in pharmacovigilance.
- Both pre and post marketing activities experience.
- Clinical and CMC knowledge.
- Proven ability to develop and maintain working relationships.
- Strong interpersonal skills are essential.
- Ability to work as part of a small team.
- Able to prioritise workload and be flexible.
For more information or to apply for this Regulatory Affairs and Pharmacovigilance job, please contact Meera Pattni on 01438 743 047 or email firstname.lastname@example.org. Please quote reference CL21401 in all correspondence.
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