Voisin Consulting, Inc is seeking an experienced Senior Regulatory Scientist in CMC to work either in Cambridge, Massachusetts or remotely. This position offers opportunities for growth and a competitive compensation package.
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;
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.;
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);
Contribute to the development of the “CMC & Quality” activity, both by growing the existing projects and by generating and taking charge of new projects. This includes meeting with prospect clients, coordinating the writing of new proposals for collaboration, and developing an efficient working relationship with the clients;
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 or biologicals) experience;
Additional 2 years of regulatory experience in the USA is preferred;
Experience with Project Management is a plus;
Strong problem solving skills;
Demonstrated ability to manage and build relationships with colleagues and regulatory authorities;
Direct interactions with the FDA is a plus;
Experience in a consulting environment is a plus.
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.