Manager Regulatory Affairs
Publication date:
04 October 2024Workload:
100%Contract type:
Permanent position- Place of work:Écully
This position reports directly to our Director of Regulatory Affairs and is part of a team of 3 people based between Lyon and Boston (US). The primary responsibilities include preparing regulatory documents, serving as the regulatory contact in the EU and associated countries for designated projects, developing processes and timelines to support the assigned regulatory activities, and tracking submissions.
Main responsibilities:
- Participate in the development of global regulatory strategy, particularly in Europe. Serve as the regulatory contact for designated projects: assist in developing timelines, preparing/supervising, and maintaining regulatory submissions.
- Prepare for interactions with regulatory authorities.
- Implement and track regulatory activities for Phase 1, 2, and 3 clinical trials.
- Support the preparation of NDAs/MAAs (New Drug Applications/Marketing Authorization Applications).
- Participate in responses to questions from health authorities and ethics committees.
- Draft documents (investigator brochure, briefing book, meeting request) in close collaboration with CMC, non-clinical, and clinical teams.
- Manage projects with service providers and regulatory experts.
- Provide support for non-EU regulatory activities as needed.
- Prepare Standard Operating Procedures (SOPs) for regulatory operations; provide regulatory review of SOPs from other departments if necessary.
Required skills:
- Master’s degree/PharmD/PhD.
- Direct experience with CTA (Clinical Trial Applications) and ODD (Orphan Drug Designation) submissions.
- Direct experience in preparing registration dossiers and interacting with agencies is a plus.
- Strong knowledge of regulations for small and large molecule product development is preferred. Experience with peptides is a plus.
- Strong project management and organizational skills with a focus on attention to detail.
- Excellent interpersonal, verbal, and written communication skills, with the ability to build relationships at all levels of the organization.
- Ability to work independently on multiple projects with tight deadlines and minimal supervision.
- Experience working with CROs (Contract Research Organizations) on regulatory submissions supporting clinical trials.
- Proficiency in MS Office products.
- Experience with cloud-based document management programs and/or document management systems and co-authoring tools is preferred.
- Certification in regulatory affairs or a similar certification is a plus.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.