Regulatory Affairs Manager – Clinical Trials – Global CRO – Remote (EMEA) £negotiable, car allowance, bonus, pension, healthcare + various other benefits
You’ll work on and manage both smaller projects as well as large-scale, complex projects. You’ll write technical regulatory documents as well as review your colleagues' documents.
The Company
This is a 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)
- A hugely successful company that has a consistent and exciting project pipeline
- The highly supportive company, they’ll work with you and support you in achieving career goals
The Role
You’ll be leading and managing high-profile, large-scale regulatory projects across multiple products/therapy areas. You’ll be working cross-functionally, liaising with stakeholders across the business, globally.
- Act as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project
- Competently writes regulatory and/or technical documents
- Give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
- May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables
- May write new regulatory standard operating procedures, and/or propose revisions and/or act as a reviewer for regulatory standard operating procedures, as assigned and appropriate.
You
To apply for this role as Regulatory Affairs Manager – Clinical Trials our client is hoping for someone with the following skills and experience
- Ample Regulatory Affairs experience within a CRO
- Pharma experience will be considered if you have clinical trials experience within Pharma
- Global regulatory knowledge
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical, and Clinical), laws, and related guidelines
- Project management skills
- Strong stakeholder management skills
What should you do next?
This Regulatory Affairs Manager – Clinical Trials role is one not to be missed; it encompasses the opportunity to manage and lead high-profile, complex regulatory projects. To discuss this Regulatory Affairs Manager – Clinical Trials 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.