Regulatory Affairs & Patient Safety Manager (post marketing) – Global CRO – UK remote – £Competitive basic salary, bonus, and benefits
This is a post-marketing regulatory affairs role combined with some patient safety activities. You’ll be working with one major pharmaceutical client ensuring their products stay up to date with legislation both from a regulatory and safety perspective.
This is fantastic opportunity to work for a global, market leading CRO in their regulatory team. Pioneers in human and data science, this CRO is at the forefront of clinical trials across multiple therapy areas.
- Global CRO, one of the front runners in clinical trials
- Covering multiple therapy areas (Oncology, Rare Diseases, GI, CNS being just a few of them)
- Hugely successful company who have a consistent and exciting project pipeline
- Highly supportive company, they’ll work with you and support you in achieving career goals
As the Regulatory Affairs & Patient Safety Manager, you will be responsible for;
- Act as the Patient Safety and Regulatory Affairs 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,
- 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.
To apply for this role as Regulatory Affairs & Patient Safety Manager, our client is hoping for someone with the following skills and experience
- Experienced Regulatory Affairs Manager specifically within post approval maintenance
- MA Transfers experience is essential
- Global experience is essential
- Degree in life science or related discipline
- Project Management experience, managing budgets of projects etc
- Patient safety experience
- Developing Regulatory submission docs, submission plans
- Knowledgeable in worldwide RA and PV Regulations and relevant ICH guidance.
What should you do next?
This Regulatory Affairs & Patient Safety Manager role is one not to be missed; it encompasses the opportunity to work for a global CRO on one of their global pharmaceutical client accounts. To discuss this Regulatory Affairs & Patient Safety Manager role further or to find out about other Regulatory Affairs jobs I’m currently working on, please get in touch or hit apply to submit your current CV.
Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.