We are looking for a highly motivated person with a client- and business-oriented mind, with the ability to work in a multicultural environment. You will be joining a team of sciences professionals committed to delivering innovative therapies to patients. At Voisin Consulting Life Sciences, we believe that product development must be driven by a solid understanding of the environment within which it will be launched, and the criteria by which elements of the development will be assessed by both regulators and payers. We start from science and medical needs, as we collaborate with our clients’ teams to drive innovative products along development and commercialization.
As a Senior Regulatory Scientist in the CMC team, your main responsibilities will be:
Write, review and assemble high quality regulatory submissions, such as Quality Modules of Marketing Authorization Applications (MAA/NDA/BLA), Investigational New Drug (IND/IMPD), Variations, pre-IND briefing documents, etc.;
Participate as team member, leader, or advisor in a number of the company’s projects, in an international environment
Serve as in-house regulatory expert for internal and external projects
Participate to the definition and implementation of CMC regulatory strategies for development and registration of innovative drugs;
Provide advice on operational and technical CMC subjects (Manufacturing, analytical development, validation, specification setting, stability, etc.);
Provide support for the preparation of Agency meetings (EU and US);
Monitor, prioritize and supervise projects’ strategy, timelines, and milestones and communicate them to the project team members;
Ensure compliance with regulations and applicable guidelines;
Stay up to date with CMC EU and US trends and requirements.
3 to 5 years proven professional CMC (small molecules and/or biologicals) experience;
Additional 2 years of regulatory experience in the USA is preferred;
Strong problem solving skills;
Demonstrated ability to manage and build relationships with colleagues and regulatory authorities;
Experience with Project Management is a plus;
Direct interactions with the FDA is a plus;
Experience in a consulting environment is a plus.
Proven ability to meet deadlines;
Proactive and enthusiastic approach to collaboration with internal and client teams;
Strong written and verbal communication, presentation, and facilitation skills;
Excellent working knowledge of MS Office (Word, Excel, PowerPoint) is essential.
Internal Number: 1
About Voisin Consulting Life Sciences
Voisin Consulting Life Sciences – Careers
Voisin Consulting Life Sciences (VCLS) is specialized in consulting services to innovative life sciences companies: biotechnology medtech and pharmaceutical , companies. VCLS supports its clients throughout product development from the design of global development plans and regulatory strategies to their implementation and submissions to regulatory agencies and payers. Its expertise encompasses the full spectrum of health products: drugs, biologics, cell and tissue therapies, medical devices/ digital, In-Vitro Diagnostics/CDx, combination products, as well as nutraceuticals and cosmeceuticals.
Our professional consultants have scientific background; they are located across Europe (London, UK; Paris & Rennes, France; Lausanne, Switzerland), the USA (Cambridge – MA, Somerville - NJ & San Francisco - CA) and Bangalore, India.
VCLS is constantly searching for talented people attracted by innovation, geographical and cultural diversity of the organization and its clients, and by the very rewarding and stimulating career opportunities offered to the employees.