Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

Curium

Paris, France

SUMMARY OF POSITION

As part of the New development and new registration Regulatory Affairs Department, you will lead the regulatory strategy and preparation of a new Marketing Authorization Application (MAA) for a key development project within the Group.

You will be responsible for defining and implementing the regulatory pathway, from early strategy through to dossier submission, working closely with CMC, Clinical, Medical, and Quality teams.

This position requires a strategic mindset combined with strong hands-on capabilities, including direct contribution to dossier preparation, critical review, and interactions with regulatory authorities.

KEY RESPONSIBILITIES

Regulatory Strategy

• Define and implement the global registration strategy (Main focus is EU, and countries of Project Orbis outside the US) in alignment with operation, clinical and commercial objectives.
• Identify and justify optimal regulatory pathways (centralised, national, reliance, abridged, etc.) and anticipate country-specific requirements.
• Develop and maintain the regulatory roadmap, including submission timelines and planned authority interactions.

Interactions with Health Authorities

• Prepare and lead pre-submission meetings with EMA, ANVISA, and TGA.
• Draft briefing documents and ensure consistency and quality of responses to agency questions.
• Act as the primary point of contact for agencies, coordinating with affiliates and local partners.

MAA Dossier Preparation and Submission

• Oversee the planning, review, and validation of CTD modules (Modules 1–5).
• Personally contribute to section preparation and review.
• Ensure technical and regulatory compliance of submissions (eCTD format, local requirements).
• Manage agency queries during the initial submission, post-submission updates, and variations as needed till the renewal.

Leadership and Cross-functional Collaboration

• Collaborate closely with internal teams (CMC, Clinical, Quality, Pharmacovigilance, Commercial).
• Supervise, when applicable, a small project team or external consultants.
• Actively contribute to regulatory intelligence and best practice sharing within the department.

Requirements

Education and Experience(s)

• Degree in Pharmacy, Chemistry, Chemical Engineering, or Biology (or a closely related field). A Master’s degree is considered a strong plus.
• 5+ years (ideally 5–10 years) in a relevant Regulatory Affairs or pharmaceutical industry role.
• Proven experience with the centralized Marketing Authorization (MA) procedure in Europe is required.

Required skills/hard skills

• Excellent communication skills in English (written and verbal).
• A solid understanding of clinical pathways for MA procedures in Europe is highly appreciated.
• Ability to interpret scientific and clinical data to support regulatory strategies.
• Strong analytical thinking and problem‑solving abilities.
• Capacity to manage multiple priorities, meet deadlines, and work independently as well as cross‑functionally.
• High attention to detail and accuracy in documentation and submissions.

Preferred skills/Soft skills

• French language proficiency.
• Familiarity with Orbis procedures and broader global regulatory environments.
• Experience in cross‑functional project coordination.
• Soft skills: Positive mindset; Adaptable to change; Solution‑oriented; Open‑minded; Able to think outside the box; Curious and proactive.