A leading global regulatory consultancy is seeking aPrincipal Consultant (CMC – Biologics)to join its fast-growing team. This senior, full-time role offers the opportunity to provide strategic regulatory and technical guidance to global clients while mentoring junior staff and shaping product development strategies across biologics and advanced therapies.
Key Responsibilities
- Deliver strategic and technical CMC regulatory advice for global drug development programs
- Author and review regulatory documents (INDs, IMPDs, MAAs, BLAs, etc.)
- Lead client engagements and represent them during regulatory interactions
- Oversee project budgets and timelines, ensuring high-quality service delivery
Requirements
- PhD/MSc/BSc in a life or physical science discipline
- 10+ years’ experience in CMC development and regulatory affairs
- Expertise with biologics, including recombinant proteins, antibodies, vaccines, biosimilars, and ATMPs
- Deep knowledge of FDA, EMA, ICH, and TGA regulatory guidelines
- Experience in authoring major submissions and representing clients before regulators
For more information, do get in touch with
At Life Sciences Recruitment Ltd (LSR), we are a Global Life Science recruitment firm that specialises in partnering with start-ups and fast-growing biotech and pharmaceutical organisations.
Founded in 2021, we recognised the need for a company with a search firm's insights, knowledge and credibility but offering a contingent service.
As one of the most competitive and fast-paced industries globally, succeeding and growing in the life sciences business requires a combination of creativity, technical expertise, and business savvy. At LSR, to find the best talent for your organisation, our dynamic recruitment consultants tap into our unparalleled network of contacts and apply a quality-based approach to a contingent search model tailored to your needs. We provide the most sought-after candidates to fit your requirements, from temporary placement to Fortune 500 companies!
LSR is a privately owned and independent recruitment company focused on the Life Sciences industry. We are a subsidiary of Morgan Prestwich (MP), Europe's leading boutique Life Sciences executive search and advisory firm.
Contact us today to learn more about our recruitment services!
