Careers

Recruiting enthusiastic regulatory professionals
at all levels to join our expanding EU team based in the UK and in France

BlueReg is recruiting and we are looking for enthusiastic Regulatory professionals with experience in EU Regulatory Affairs.

A highly qualified team : over 50 full time consultants with varied profiles, backgrounds and skills, working with enthusiasm and a strong winning spirit in order to address our clients needs and expectations.

BlueReg has over 100 clients ranging from large multinationals to small start-up companies, from innovators to generic companies.

If you are interested in joining our dynamic and dedicated team whose members are committed to working together to provide clients with a high-quality service, please send a copy of your CV and a cover letter to :

contact@blue-reg.com or click apply below.

careers-1

Why work at BlueReg ?

We are a growing company which invests in our people by encouraging training and development to ensure continued professional growth.

Working at BlueReg will give you the opportunity to expand your knowledge in multiple areas or become an expert in a specific area.

We are a friendly team that offers a flexible working environment and encourages a good work-life balance.

In Bluereg you will work in a project management mode with multi cultural teams and acquire a global expertise.

WHY-WORK-AT-BLUEREG

What our people say about working at BlueReg

‘’BlueReg is a varied team of experienced professionals, with a strong investment in the development of employees, providing a supportive and encouraging environment to continuously improve expertise, learn from one another and evolve to meet the needs of clients and the regulatory environment. BlueReg strives for excellence and it is a pleasure to be part of such an ambitious, enthusiastic and nurturing company.’’

Nicole consultant

‘’BlueReg is a dynamic and flexible company that gives excellent opportunities for consultants to develop in an enjoyable environment.’’

Justine consultant

‘’When I joined Blue-Reg, what particularly impressed me was the wide range of expertise covered by its employees. Each participant occupies a well-defined place, there is no sense of competition but solid teamwork in which all members are invested in one main goal: to permanently deliver quality services to their clients. Blue-Reg is a big family where I feel I play an important role, I am well-supported, continually trained and my work is acknowledged for its true worth. Blue-Reg’s dynamism, wide expertise, ever increasing development and good customer satisfaction are its principal strengths. I am proud to work for such a challenging company!’’

Sylvie consultant

Our offers

Consultant(e) Sénior – Management de la Qualité France Sophia Antipolis or Paris

Vos Missions :

Au sein de l’équipe Affaires Réglementaires France, vous participerez activement aux activités
de Blue-Reg et à différentes missions confiées par nos clients (Industries de Santé),
notamment :

  • Activités de conseil ou gestion de sujets relatifs au management de la qualité pour des
    établissements pharmaceutiques Exploitant
  • Conseil et support en matière de demande d’ouverture d’établissements pharmaceutiques
    et de mise en place de Systèmes de Management de la Qualité
  • Conduite d’audits exploitant pré-inspection, de fabricants, de distributeurs ou de prestataires
  • Contribution à l’analyse et à la rédaction des revues annuelles qualité produits pour des
    établissements pharmaceutiques Exploitant
  • Conseil et accompagnement en matière de certification de la visite médicale.

Votre Profil :

  • Vous êtes Pharmacien et vous avez une expérience significative et actuelle en management
    de la qualité acquise dans l’industrie pharmaceutique depuis au moins 6 à 8 ans
    Votre dynamisme et aptitude à rédiger et communiquer sont reconnus et vous avez une expérience
    de gestion de projet.
  • Votre expertise technique, votre capacité d’écoute, votre esprit de synthèse et le sens du client
    pourront vous permettent d’interagir de façon autonome avec vos interlocuteurs et d’identifier
    rapidement les réponses aux questions qui vous sont posées.
  • Vous avez une très bonne maîtrise des outils informatiques ainsi que de l’anglais, à l’oral
    comme à l’écrit.

Le poste est basé à Paris ou Sophia-Antipolis.

Merci d’adresser votre candidature à contact@blue-reg.com.

Apply

Expert DMOS et Transparence (CDI) France Sophia Antipolis or Paris

BlueReg est une société de conseil spécialisée en affaires réglementaires, développement de médicaments, pharmacovigilance et qualité pharmaceutique. Nous proposons une gamme étendue de prestations pour les laboratoires pharmaceutiques tout au long de la vie du médicament (de son développement aux activités post – AMM).

 

Nous recherchons : Un(e) expert DMOS et Transparence (CDI)

 

Vos Missions :

 

Au sein de l’équipe BlueReg France, vous participerez activement aux activités de BlueReg et vous assurez l’interface avec nos clients (industries de santé) pour différentes missions qui nous sont confiées, notamment :

 

Loi anti-cadeau (DMOS) et transparence des liens d’intérêt :

 

  • Etre le référent vis-à-vis de nos clients sur les questions relatives à la loi DMOS et à la transparence des liens (médicaments, dispositifs médicaux)
  • Mise en place de processus pour la gestion des évènements (hospitalité, contrats, etc.), rédaction de procédures
  • Conseil et évaluation de la conformité des événements (hospitalité, contrats) ; soumission et suivi des dossiers auprès des conseils de l’ordre
  • Gestion du processus de collecte, consolidation et contrôle des informations relatives à la publication des liens sur le site unique public de la transparence
  • Actions de formation en DMOS et Transparence des liens
  • Coordination des activités liées à la loi DMOS et à la transparence

 

Votre Profil :

 

De formation Bac + 3, vous justifiez d’une expérience significative (5 ans minimum) acquise dans un département juridique, conformité, ou affaires réglementaires d’une industrie de santé qui vous a permis d’acquérir une maîtrise de la réglementation régissant les relations avec les professionnels de santé et la Transparence des liens d’intérêt. Une formation de type Droit des affaires/Droit de la Santé serait un plus.

 

Votre dynamisme et votre aptitude à communiquer sont reconnus et vous avez une expérience de gestion de projet.

 

Votre expertise technique, votre capacité d’écoute, votre esprit de synthèse et le sens du client pourront vous permettent d’interagir de façon autonome avec vos interlocuteurs et d’identifier rapidement les réponses aux questions qui vous sont posées.

 

Vous avez une très bonne maîtrise des outils informatiques ainsi que de l’anglais, à l’oral comme à l’écrit.

 

Le poste est basé à Paris ou Sophia Antipolis.

 

Merci d’adresser votre candidature à contact@blue-reg.com

Apply

Senior Consultant, Scientific Writing France Sophia Antipolis or Paris

BlueReg Group is a consultancy company specialized in Development, Regulatory Affairs, quality management and Pharmacovigilance for the Pharmaceutical Industry.

Based in Paris, Sophia Antipolis and London, BlueReg Group has over 100 clients ranging from large multinationals to small start-up companies, from innovators to generic companies. BlueReg was founded in 2011 and, since then, has experienced significant year-on-year growth. In the context of its continued growth, BlueReg Europe is currently seeking a:

Senior Consultant, Scientific Writing

Within the Global Regulatory team, you actively provide tailored consultancy services for a range of clients, from ad hoc advice to long term partnership:

 

Key duties and responsibilities:

 

With minimum senior management supervision, you plan and implement the writing strategy of regulatory documents for drug development, registration and maintenance activities for Europe and US.

 

You achieve all the activities linked to the scientific support and writing of regulatory documents, especially:

  • Liaise with authors and clients
  • Advice and support on regulatory and scientific aspects to clients
  • Lead process of document reviews
    • Writing of scientific and regulatory documents such as: o Briefing documents for scientific advice (EU, US)
    • o Orphan Drug Designation request (ODD)
    • o Paediatric Investigation Plan (PIP)/ Paediatric Study Plan (PSP)
    • o Investigational Medicinal Product Dossier (IMPD)/ Investigational New Drug (IND)
    • o Investigator’s Brochure (IB)
    • o Clinical Study Report (CSR)
    • o CTD modules for MAA (or variations) : Non Clinical and Clinical Summaries and Overviews, Risk Management Plan
    • o Responses to Agencies questions

 

As part of your activities, you bring your expertise to all Blue Reg teams and are required to contribute to various projects.

 

Education and skills:

 

  • Pharmacist / Engineer / Life Sciences Graduate
  • Between 5 to 10 years’ experience in Scientific Writing
  • English as native language or fluent in English (written and spoken)
  • Excellent verbal and written communication skills
  • Good organizational skills with ability to work on multiple projects or activities in parallel
  • Good analytical skills
  • Team spirit

 

This position is based in Sophia Antipolis (South of France) or Paris or London (UK). Can also be home based.

Please send a copy of your CV and a cover letter to rh@blue-reg.com and cance.peggy@blue-reg.com

Apply

Senior Consultant, Regulatory Affairs UNITED KINGDOM London

BlueReg Group is a consultancy company specialized in Development, Regulatory Affairs, quality management and Pharmacovigilance for the Pharmaceutical Industry.

 

Based in Paris, Sophia Antipolis and London, BlueReg Group has over 100 clients ranging from large multinationals to small start-up companies, from innovators to generic companies.

 

We are recruiting: Senior Consultant, Regulatory Affairs (EU and UK/Ireland)

 

Your key duties and responsibilities:

  • Is a source of regulatory expertise in the development, registration and post-licensing activities of pharmaceutical products
  • Project management activities
  • People management / Review of work of junior personnel and BlueReg partners
  • Ensures high quality and on time delivery of consulting services to clients
  • Contributes to the effective functioning and to the business growth of BlueReg EU.

 

Your profile :

  • Pharmacist, Life Sciences Graduate, ideally with post-graduate qualification
  • Sound knowledge of pharmaceutical regulations and guidelines
  • Significant regulatory affairs experience including a successful track record in the registration of medicinal products
  • A least 10 year experience in the pharmaceutical industry, broadly based Regulatory.

 

Affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within Europe and UK/Ireland.

You have excellent written and verbal communication skills, good organisational and analytical skills. You are fluent in written and spoken English.

This position is based in High Wycombe, UK.

Apply

Regulatory Affairs professional UNITED KINGDOM London

BlueReg was founded in 2011 and since then has seen significant year-on-year growth.  It comprises a team of highly experienced full-time employees who have proven track records within the pharmaceutical industry, based in offices in Sophia Antipolis & Paris (France) and High Wycombe (UK).

 

BlueReg has over 100 clients ranging from large multi-nationals to small biotech companies, from innovators to generic companies.

 

We are currently recruiting a Regulatory professional for our UK/Ireland team, based in the High Wycombe office.  The successful candidate will have industry experience of providing national Regulatory support as well as experience in healthcare compliance and promotional copy review.  If you want to join this dynamic and dedicated team whose members are committed to working together to provide clients with a high quality service, please send a copy of your CV and a cover letter to contact@blue-reg.com.

Apply

Discover our last white Paper

Learn more