Gör ditt nästa karriärsteg med hjälp av oss.
To our customer - a Pharmaceutical Company active within oncology with an innovative product in the early stages of product development – we are looking for an experienced CMC Consultant.
The consultancy assignment will start on a part-time basis with limited hours and may be expanded over time depending on the progress of the development process. Preferably you live in Skåne.
THE ROLE
RESPONSIBILITIES
The project is in the concept phase, and the main focus of the role is to guide, advise and act as a strategic sounding board throughout the CMC development process.
You will help shape the overall CMC strategy — including how to position and present CMC data and rationale to regulatory authorities such as the FDA — and advise on the design, composition and specifications of the test package, as well as on the repetition or modification of studies and tests to ensure scientific robustness, mitigate risks, and maintain regulatory alignment. You will contribute with your expertise to secure a solid and credible development path towards successful drug filing.
COMPETENCE REQUIREMENTS
-Solid experience in pharmaceutical product development.
-Strong understanding of regulatory requirements within the pharmaceutical industry (US, EU).
-Experience from product development projects, including pre-CMC activities.
-Proven ability to compile documentation for regulatory dossiers, with a focus on CMC sections.
-Experience working in or with a start-up or early-stage company environment.
-Strategic mindset and ability to provide rational, well-founded recommendations to support key decisions.
Interested? For more information, please contact us at Brice Group;
Morgan Eilenberg, +46 733 590 550, morgan.eilenberg@brice.se
Adina Lekberg Salamon, +46 73 974 43 34, adina.lekbergsalamon@brice.se