We are looking for a seasoned professional with global regulatory affairs experience to join our Montpellier, France facility to participate in our on-going success as a financially sound, fast-growing, socially responsible company dedicated to Global Health.
As the Senior Regulatory Affairs Leader reporting to the Head of Technical and Pharmaceutical Operations, you will work collaboratively with the Regulatory Affairs team and cross-functional Product Development teams to ensure global regulatory strategies are developed and executed, enabling successful filings with Health Authorities. Programs will be in various stages of development, with complex international activities and regulatory scenarios. Your scope will include all global regulatory submissions (NDAs, BLAs, MAAs, INDs, IMPDs, and supplementals) as well as amendments / supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, label updates, etc.
- Define the strategic regulatory priorities, pathways and plans in close alignment with the Product Development Teams, Non-Clinical Development and Clinical Development.
- Present business cases, defend and get endorsement of the regulatory strategic plans with the appropriate governance committees of the company (Development Committee, Strategic Investment Committee).
- Support the different functions within the Regulatory Team with his/her expertise and leadership (regulatory documents writing, submissions, responses to Authorities, pre-IND meetings, scientific advice, etc.)
- Ensure that the operational Regulatory Affairs process is aligned with the company Standard Operation Procedures (SOPs) and help to improve current SOPs.
- Build and maintain a strong network of internal and external collaborators, opinion leaders, and competent authorities.
- Support the Technical & Pharmaceutical Operations department with Continuous Improvement activities, to develop our position as center of Regulatory Affairs Excellence for MedinCell and external partners.
- Incorporate expert knowledge and advice, scientific and commercial considerations, and strategic business needs into the design and implementation of Regulatory Affairs plans
- Define and implement Regulatory Affairs projects including objectives, work plans, milestones and deliverables
- Provide leadership for MedinCell in the planning and execution of regulatory submissions for various products, including pre-approval and future post marketing submissions
- Facilitate global regulatory team meetings and cross-functional submission team meetings to oversee, plan and finalize regulatory submissions
- Lead, manage and participate in meetings with regulatory authorities and agency meetings, including planning, coordination and preparation for meetings and teleconferences
- Provide technical data packages to development partners for preparation of their own submissions
- Ensure application of project management practices including preparation of agendas, documentation of decisions, development and active management of timelines, effective issue and risk management
- Collaborate with responsible departments and lead preparation, review, and collection of documentation for regulatory submissions; provide a critical review of all documentation supporting regulatory applications
- Write submission documents to support development project plans and timelines for DMF, IND/IMPD, and NDA/MAA and related submissions, as well as amendments, supplements, and variations related to these applications, as well as responses to Regulatory Agency requests
- Create and maintain regulatory timelines and track deliverables to timelines to ensure that internal and partner regulatory submission timelines are met
- Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements
- Serve as a cross-functional leader and subject matter expert in Regulatory Affairs
- Maintain updated knowledge of current global regulations and guidance governing drugs and biologics in all phases of development
- Lead Regulatory Affairs involvement in related projects and variations, e.g. large-scale manufacturing site changes, specifications changes, process changes, etc.
- Recruit best talent and manage the Regulatory Affairs team
- Minimum eight (8) years of experience in pharmaceutical Regulatory Affairs
- Ideally PharmD, or Degree in Life Sciences
- Strong hands-on experience in all phases of Global Regulatory Affairs submissions from initiation to post-market variations and approvals
- Thorough understanding of ICH GCP guidelines
- Experience in working in pharmaceutical development partnerships such as co-development agreements
- Expert knowledge of drug development processes and regulations
- Regulatory experience specifically in injectables. Experience in drug delivery systems (DDS) is a plus
- Ability to manage multiple priorities with tight deadlines and anticipate and resolve issues on a daily basis
- Strong stakeholder management
- Fluency in English and a good understanding of spoken and written French