Senior Manager, Global Regulatory Affairs

il y a 3 jours

BoulogneBillancourt, Île-de-France Meet Life Sciences Temps plein

Senior Manager, Global Regulatory Affairs

Location: Hybrid – France (Boulogne)

Employment Type: Full-time

About the Role

We are partnering with a global biopharmaceutical company to support the hire of a Senior Manager within their Global Regulatory Affairs (GRA) team. These hires follow an internal move and a recent resignation, presenting an exciting opportunity to join a growing function with international scope.

As a Senior Manager in Global Regulatory Affairs , you will be accountable for regulatory strategy, submissions, and lifecycle management across global programs. You'll work closely with cross-functional teams in R&D, franchise, operations, and commercial while acting as a key liaison with health authorities worldwide.

Key Responsibilities

  • Develop and implement regulatory strategies for assigned programs at regional or global levels
  • Serve as the main regulatory point of contact across internal teams and external regulators
  • Provide strategic input into target product profiles, clinical development, and asset plans
  • Plan and lead global submissions and regulatory interactions (e.g. Scientific Advice, FDA meetings)
  • Identify regulatory risks and develop mitigation strategies
  • Monitor regulatory trends and competitor activity relevant to assigned therapeutic areas
  • Build relationships with regulators to support long-term strategic alignment
  • Drive operational excellence within the regulatory function
  • Ensure global compliance and alignment with ethical standards
  • Support due diligence efforts for external opportunities

Required Qualifications

  • Advanced degree (or equivalent) in a scientific discipline (e.g. Pharmacy, Medicine, Chemistry, Biological Sciences)
  • Significant experience in the pharmaceutical industry, including 7+ years in Regulatory Affairs
  • Proven ability to lead global regulatory strategy and manage complex projects
  • In-depth understanding of ICH, FDA, EMA, and international regulatory frameworks
  • Experience preparing and executing global submissions and health authority engagements
  • Strong project management, communication, and cross-functional leadership skills

Preferred Qualifications

  • Experience in rare diseases , drug-device combinations , or medical devices
  • Familiarity with global regulatory frameworks and submission processes
  • Prior involvement in external influencing activities or trade associations
  • Comfortable working in a hybrid and matrix team environment

Additional Information

  • Standard Monday–Friday schedule
  • Hybrid model: ~3 days per week onsite in Boulogne, France

This is a unique opportunity to join an organisation focused on innovation and patient outcomes. If you have strong regulatory experience and are looking for your next challenge in a globally visible role, we'd love to hear from you.

Apply now to learn more.

  • Senior Manager

    il y a 3 jours

    Boulogne-Billancourt, Île-de-France Meet Life Sciences Temps plein

    Senior Manager, Global Regulatory Affairs Location: Hybrid – France (Boulogne)Employment Type: Full-time We are partnering with a global biopharmaceutical company to support the hire of a Senior Manager within their Global Regulatory Affairs (GRA) team. These hires follow an internal move and a recent resignation, presenting an exciting opportunity...

  • Senior Manager

    il y a 5 jours

    Boulogne-Billancourt, Île-de-France Meet Life Sciences Temps plein

    Senior Manager, Global Regulatory Affairs Location: Hybrid – France (Boulogne) Employment Type: Full-time We are partnering with a global biopharmaceutical company to support the hire of a Senior Manager within their Global Regulatory Affairs (GRA) team. These hires follow an internal move and a recent resignation, presenting an exciting...

  • Global Sales Enablement Manager

    il y a 2 jours

    Boulogne-Billancourt, Île-de-France Sidetrade Temps plein

    Are you interested in joining a fast-growing international company that is a leader in its market? Are you ready to tackle stimulating challenges targeting large enterprises? Passionate about Technology and Global Organizations?Come and join us Sidetrade is a global SaaS provider recognized as a Leader by Gartner in its Magic Quadrant. ( You will become a...

  • Brand PR Senior Manager

    il y a 1 jour

    Boulogne-Billancourt, Île-de-France Barilla Group Temps plein

    At Barilla, we believe that every great journey begins with passion and a bold vision. From our humble beginnings in 1877 in a small shop in Parma, Italy, we've blossomed into a global leader in the food industry, guided by our commitment to progress and excellence.Today, Barilla is an international group present in more than 100 countries and we are proud...

  • Consultant(e) Senior Change Management

    il y a 1 jour

    Boulogne-Billancourt, Île-de-France Renault Group Temps plein

    Consultant(e) Senior Change Management (F/H)Consultant(e) Senior Change Management (F/H)Apply locations Boulogne Billancourt time type Full time posted on Posted 4 Days Ago time left to apply End Date: March 28, 2025 (30+ days left to apply) job requisition id JOBREQ_50199970CompanyRENAULT s.a.s.Job DescriptionVotre environnement :Depuis l'achèvement du...

  • Information Security Compliance Manager

    il y a 2 jours

    Boulogne-Billancourt, Île-de-France Sidetrade Temps plein

    Calling all tech enthusiasts Are you a problem-solving, curious, and strategic Information Security Compliance Manager? Join us at Sidetrade, the leading global SaaS provider recognized by Gartner.( About Sidetrade and its amazing R&D teamSidetrade is a fast-growing international software company that is transforming the Order-to-Cash process for global...

  • Senior Executive Assistant

    il y a 2 jours

    Boulogne-Billancourt, Île-de-France Exclusive Networks Temps plein

    Senior Executive Assistant EXCLUSIVE NETWORKS | Introduction ​ Since being founded in Paris in , we have massively expanded our global coverage and now have offices in over 50 countries across 5 continents. Exclusive Networks is the global trusted digital infrastructure specialist driving the transition to a...

  • Procurement Manager

    il y a 1 jour

    Boulogne-Billancourt, Île-de-France Voisin Consulting Life Sciences (VCLS) Temps plein

    VCLS is looking for an experienced Indirect Procurement Manager with a life sciences background to lead supplier management globally. You'll play a key role in optimizing cost, quality, and service across our procurement operations, ensuring alignment with business needs.Key Responsibilities:Develop and implement a global supplier management strategyDefine...

  • Senior Manager mission audit

    il y a 3 semaines

    Boulogne-Billancourt, Île-de-France SELESCOPE Temps plein

    Poste : Aujourd'hui manager au sein d'un cabinet reconnu (big 4 ou autre), vous avez la conviction que votre métier dépasse la seule expertise technique et consiste avant tout à apporter de la valeur à vos clients en jouant un rôle de business partner et de conseil.Vous appuyant sur votre expérience, vous souhaitez...

  • Consultant.e Senior/ Manager en Transformation

    il y a 1 jour

    Boulogne-Billancourt, Île-de-France Aneo Sas Temps plein

    Aneo est une agence de conseil fondée en 2002, qui accompagne ses clients (entreprises du CAC 40, PME, ETI et startups) dans leur transformation digitale. Une agence hybride entre le conseil en organisation, le management, et le conseil en technologie.Pour renforcer notre communauté dédiée au management des organisations, nous recherchons un.e...

  • Group Export Control Manager

    il y a 2 jours

    Boulogne-Billancourt, Île-de-France Exclusive Networks Temps plein

    About the role ​ The primary role of this position is to ensure Exclusive Networks group's compliance with all Export Control regulations relative to Dual-Use Goods to mitigate risks of non-compliance at both worldwide and organization-wide level. Beyond this strategic role, evolving in a fast-growing organization, candidate will have a pivot...

  • NetSuite Senior Developer

    il y a 1 jour

    Boulogne-Billancourt, Île-de-France Ignition Technology Temps plein

    Exclusive Networks (EXN) is a global cybersecurity specialist that provides partners and end-customers with a wide range of services and product portfolios via proven routes to market. With offices in over 45 countries and the ability to serve customers in over 170 countries, we combine a local perspective with the scale and delivery of a single global...

  • Senior Full Stack Developer

    il y a 2 jours

    Boulogne-Billancourt, Île-de-France Sidetrade Temps plein

    Calling all tech enthusiasts Are you a problem-solving, curious, and strategic Senior Full Stack Developer & People Manager? Join us at Sidetrade, the leading global SaaS provider recognized by Gartner.(https://go.sidetrade.com/GartnerMagicQuadrant22.ht)Indulge your passion for high-availability software and performance enhancement as part of our dynamic...

  • Consultant Senior/ Manager Stratégie Sociale H/F

    il y a 4 semaines

    Boulogne-Billancourt, Île-de-France ALERYS Temps plein

    Poste : Votre rôle au sein d'Oneida : En rejoignant notre équipe, vous serez un partenaire clé des Directions Générales, Directions des Ressources Humaines, et plus largement des instances dirigeantes de nos clients en France et à l'international.Vous serez un acteur clé de la bonne réalisation des missions et vous pourrez...

  • Senior UGC Manager UGC Strategist

    il y a 16 heures

    Boulogne-Billancourt, Île-de-France MWM Temps plein

    MEETING MWMFounded in 2012 by JeanBaptiste Hironde MWM is a global leader in developing and publishing mobile applications in creative domains with over 600 million downloads worldwide. Recognized asthe top French app publisher we are known for our innovative approach and a touch of madness that inspires unconventional thinking.True to our vision ofmaking...

  • Responsable Data Management Senior Expérimenté

    il y a 2 semaines

    Boulogne-Billancourt, Île-de-France Astek Temps plein

    Groupe français indépendant, avec un CA de 358 m€ en 2021, Astek est devenu en plus de 30 ans un acteur majeur de l'ingénierie et du conseil en technologies (5800 collaborateurs en France et à l'international, dont 90% d'ingénieurs). Implanté au plus près de ses clients, le groupe axe son intervention sur les réalisations de projets à haute valeur...

  • Responsable Data Management Senior Expérimenté

    il y a 2 semaines

    Boulogne-Billancourt, Île-de-France Astek Temps plein

    Groupe français indépendant, avec un CA de 358 m€ en 2021, Astek est devenu en plus de 30 ans un acteur majeur de l'ingénierie et du conseil en technologies (5800 collaborateurs en France et à l'international, dont 90% d'ingénieurs). Implanté au plus près de ses clients, le groupe axe son intervention sur les réalisations de projets à haute valeur...

  • Global IT Administrator Cybersecurity and Cloud Infrastructure HF

    il y a 1 jour

    Boulogne-Billancourt, Île-de-France EURHASI Temps plein

    EURHASI recuits for its client a Global IT Administrator Cybersecurity and Cloud Infrastructure H/FOur client is an International Industrial Group is a global company with 17 facilities across several continents. Each site operates its own local IT infrastructure but the company follows a global strategy to harmonize processes enhance cybersecurity and...

  • Ingénieur Procédés Senior H/F

    il y a 1 jour

    Boulogne-Billancourt, Île-de-France Aldebaran Group Temps plein

    Ingénieur Procédés Senior - Ref. JOB-1341RECAPITULATIF :Prêt à relever des défis passionnants dans le domaine de l'Energie ?Nous recherchons un Ingénieur Procédés Senior, pour soutenir le développement d'un projet dans le traitement de l'eau depuis l'ile de France.Vous contribuerez au Basic Engineering, au Detail Engineering et au démarrage du...

  • Global IT Administrator Cybersecurity and Cloud Infrastructure

    il y a 16 heures

    Boulogne-Billancourt, Île-de-France The French Sourcer Temps plein

    The French Sourcer is seeking a Global IT Administrator Cybersecurity and Cloud Infrastructure. Our client is a global industrial group with 17 facilities across multiple continents. Each site manages its own IT infrastructure while following a unified strategy to standardize processes enhance cybersecurity and optimize shared tools. Their key platforms...