In the context of a new project, we are looking for a Junior Global Regulatory Lead to join the teams of our client in Suresnes (Paris Region), France.

Group 10
Responsibilities

  • Understand key features of the product(s) and relevant regulatory trends and competition across major markets (e.g., guidelines, precedent) needed to assess the outcomes of regulatory strategy(ies) throughout the product(s) lifecycle. e.g., novel evidence generation, accelerated pathways, orphan, legal basis,…).
  • Ensure collaboration across internal stakeholders (e.g., Clinical sub Team) to create and maintain the indication/project global regulatory strategy aligned with the Regulatory Strategy Document
  • Lead the indication/project regulatory strategy (e.g., ODD, registration, LCM) and major Health Authorities interactions (e.g., EMA, FDA, PMDA, CDE) in close collaboration with RRLs/LRA (HA primary point of contact) (exceptionally GRL may be HA contact for US and/or EU).
  • Lead the label development of indication/project (i.e : Product information) and Company Core Data Sheet (CCDS), in collaboration with Labeling representative(s)
  • Work along submission management and regional leads to design regulatory submission plan
  • Act as a core member of the Global Regulatory Team.
  • Be responsible for the Reference Dossier of indication/project and oversees updates for line extensions, market expansion and/or variations.
  • Be responsible for consistency and timely delivery of regulatory documentation for the indication/project throughout the life cycle (e.g., CTA/IND documents, core briefing book, slide set, Q&A, PIP/PSP, CTD Modules) to enable submission timelines.
  • Conduct the development and maintenance of the Regulatory Risk Register to support Indication/Project Team(s).
  • Provide support to RRL/LRA in key markets to facilitate registration procedures.
  • For CTA/IND, ensure that available regulatory documentation satisfies requirements necessary for study implementation (e.g., regulatory toxicology studies)
  • For CTA/IND, ensure the regulatory impact assessment in case of new findings (quality, efficacy or safety)

Group 11
Education & Experience

  • Master’s degree or more in a Life Sciences related field. A Pharm D, a MD or a PhD would be a plus.
  • 3-5 years of experience in Regulatory Affairs managing regulatory process and registration aspects of the drug development process within the Pharmaceutical Industry
  • Previous experience in a regional or national regulatory manager role is highly desirable.
  • Experience in different therapeutic areas and stages of the product life cycle is a plus. Equivalent experience in a regulatory agency or in a relevant drug development role will also be considered

Group 13
Profile

Hard/Technical skills:

  • Demonstrated knowledge of global regulatory procedures and requirements (in particular ICH, FDA and EMA guidelines and requirements)
  • Ability to execute project goals within a cross-functional environment, understanding stakeholder needs
  • Fluent in English. Good knowledge of French is an advantage

Soft skills:

  • Good oral and written communication skills, ability to deal with difficult situations
  • Agility to combine a global vision and ability to execute
  • Demonstrated analytical and problem solving skills
  • Action-oriented and results driven
  • Ability to work collaboratively in multi-functional teams and networking
  • Demonstrated ability to successfully prioritize multiple global tasks, projects and objectives within a defined portfolio
  • Demonstrated organizational credibility by means of demonstrated success

Junior Global Regulatory Lead - 673