BlueReg Group / Careers
BlueReg is continously recruiting and we are always looking for enthusiastic Regulatory professionals with experience in EU Regulatory Affairs.
A highly qualified team : over 60 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 :
firstname.lastname@example.org or click apply below.
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.
‘’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.’’
‘’BlueReg is a dynamic and flexible company that gives excellent opportunities for consultants to develop in an enjoyable environment.’’
‘’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!’’
Blue Reg Group is a consultancy organization specialized in Development, Regulatory Affairs, Pharmacovigilance, Market Access and Quality Management for the Pharmaceutical Industry.
Located in Paris, Sophia-Antipolis and London, we provide strategic advice and hands-on outsourcing solutions to life science companies through the entire lifecycle of their products.
We are currently seeking a: Senior Consultant, Regulatory Affairs
Within the Global Operations Unit, you actively provide tailored regulatory consultancy services for a range of clients, from ad hoc advice to long term partnership:
Key duties and responsibilities are summarized below
You are a source of expertise in the registration and post-licensing activities of pharmaceutical products or other health products:
• Registration (e.g. coordination of EU procedures, responses to questions, experience with export countries).
• Post MAA (e.g. preparation and submission of variations, advice on classification and documentation required, MA holder transfers, renewals, PSUSA).
• Supports the regulatory local launch activities at global level and early access program (set up the regulatory launch strategy, coordinates local partners, compiles local requirements).
• Global regulatory promotional materials review & validation: reviews and validates promo-tional materials from a regulatory point of view as per EFPIA/IFPIA guidelines, coordinates partners.
• Writing of regulatory documents.
• Interaction with agencies and partners.
• Conducts due diligence on the regulatory part of dossier/company.
• If possible, you are also experienced in development and regulatory strategy (e.g. scientific Advice, ODD, PIP, CTA).
You ensure high quality and on time delivery to clients to maintain client satisfaction.As part of your activities, you bring your expertise to all Blue Reg teams and are required to contribute to various projects.
• A least 7 to 10 years’ 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/or at export.
• Experience in consultancy would be a plus.
Education and skills
• Pharmacist / Engineer / Life Sciences Graduate.
• 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 multi-projects in a multi-cultural and matrix environment.
• a global environment.
• Established relationships and proven negotiation skills with management, colleagues and/or regulators • Decisive and proactive, with “small company” hands-on, can-do style and attitude.
• Good analytical skills.
• Team spirit.
This position is based in UK (High Wycombe). Can also be partly home based.
Please send a copy of your CV and a cover letter with mention in object to email@example.com with mention in object : « Application Senior Consultant, Regulatory Affairs – Name, Forename »Apply