- Deliver CTA regulatory strategies & operations for a designated portfolio of development compounds in the specified geographic region: WE, EEMEA, LA, and specified JAPAC countries in alignment with the overarching global regulatory strategy and region-specific requirements.
- Ensure the submission strategy for clinical trials planned globally are in accordance with the overarching global regulatory strategy and any risks and issues are highlighted to the Global Regulatory Project Team (GRPT) and study teams within the development operations organization.
- Ensure study deliverables are achieved in accordance with global regulatory strategies and compliance with evolving global clinical trial legislation (including the EU Clinical Trial Regulation) and company procedures.
- and implement regulatory strategies and deliverables for global clinical trial applications in accordance with the overarching global regulatory strategy considering regional specific requirements.
- EU Clinical Trial Application forms, review CTA documents to ensure compliance with current requirements and in accordance with other regulatory factors e.g. scientific advice/PIPs. Provide Subject Matter Expert advice on the Clinical Trial Directive 2001/20/EC, and Regulation 536/2014 and on regulatory requirements to obtain approval of clinical trials in specified countries.
- to live and work in the United Kingdom
- experience working on EU CTR Submissions
- Life Sciences degree or equivalent
- years of Regulatory experience with a strong background in EU submissions.
- strong CTA background with previous experience authoring CTA packages, driving strategies and working on global submissions.
Regulatory Affairs Manager - Windsor, United Kingdom - Cpl Life Sciences
Description
Job Description
Job Title: Regulatory Affairs Manager CTA, CTR (Consultant)
Job Type: 12 Month Contract
Location: Berkshire, UK – Hybrid
Rate: £50-55 per hour (inside IR35)
We are partnered with a leading Pharmaceutical organisation who are looking for an experienced Regulatory Consultant to join on a 12-month contract basis. This role will be sat in the core regulatory CTA team and will be accountable for end-to-end CTA processes. This role will support EU CTR Transitions and initial submissions as well as global CTA submissions.
This role will require the right candidates to have experience with EU CTR submission including being involved in initial CTR submissions as well as a number of transitions.
Job Responsibilities include;
Candidate Requirements include;
Please note this position falls inside IR35 and has no opportunities to go through LTD, if this position is of interest to you please forward your up-to-date CV to
The role does not offer Sponsorship and needs the right candidates to be on-site 3x a week in Berkshire, UK.