Role: Regulatory Affairs and Patient Safety Manger
Location: UK or Europe
Work Arrangement: Home based
Salary: Attractive salary + package
About the role
Leading a broad cross-functional Core Transition team, comprised of functional representatives, you will act as the Patient Safety (PS) and Regulatory Affairs (RA) Workstream lead in the core transition team for marketing authorization transfers.
Leading a team of key functional activity leads to provide management of transition activities to relevant project milestones, as well as core delivery activities for marketing authorization transfers, including but are not limited to: Submission/tracking Process, Regulatory Activities, Pharmacovigilance Agreement (PVA) and Document/Information Transfer. Interfacing with clients to agree joint dashboard reporting for the workstream, as well as to agree ways of working for the joint workstream team, status discussions, issue/risk discussions, etc.
Do you meet the required skills, experience, and educational requirement for the role?
Specific Skills required:
- Highly organized, proactive, and detail oriented
- Experienced communicator and facilitator
- Effective time manager
- Proficient in standard business productivity tools (e.g. Microsoft Office package)
- Strong understanding of template standard language for PV Agreement
- Working knowledge of Regulatory and Patient Safety legislation, worldwide, and standard documentation/ document types including understanding of GDP, GVP.
- Strong team building capabilities
- Good organization and problem-solving skills
- Ability to establish and maintain effective working relationships with a diverse set of global internal/external cross functional co-workers, managers and clients
- Bachelor's Degree Degree in Lifescience or related discipline Req Or
- Master's Degree Degree in Lifescience or related discipline
- Project Management experience in a role leading similar sized efforts, usually demonstrated by 2 or more years experience.
- Regulatory (Reg Affairs and Patient Safety (PS)/ PV) experience including assisting in the developing regulatory submission documents and coordinating delivery to submission plans, usually demonstrated by 6 + year exposure.
- Experience in Regulatory affairs or Patient Safety role with exposure to (reviewing/authoring) PVAs
- Experience in regulatory requirements for asset transfers
- Knowledgeable in worldwide RA and PV Regulations and relevant ICH guidance
Please apply if you are interested, or email directly at email@example.com
- Agency: Cpl Life Sciences
- Reference: JO-2204-491464
Website: Cpl Life Sciences
- Posted: 27th April 2022
- Expires: 25th May 2022