Regulatory Affairs Manager CMC Development
Global pharmaceutical company with a HQ based in French part of Switzerland is currently growing their technical operations department and they are looking for a senior regulatory affairs manager with CMC expertise in biological products.
lead the dossier content and interaction with CMC technical functions (the CMC section of the CMC strategy document and contribution to risk assessment, strategic support)
Provide support during Health Authority interactions on CMC (the CMC regulatory/dossier strategy, strategic planning in collaboration with Global Regulator Affairs, authoring, review and approval of all regulatory relevant quality documents)
Be accountable and responsible for translation and interpretation of the country regulatory requirements into CMC/Technical requirements
Responsible for the creation of the quality files for products
Responsible for performance and preparation of regulatory compliance audits and inspections at the sites including CMOs.
Provide profound expertise in pharmaceutical legislation and application of current regulatory guidance including pharmacopeia requirements for the pharmaceutical areas.
Expert assessment in out licensing projects for business development
· Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
· Minimum of 7 years of pharmaceutical industry experience including global CMC regulatory experience
Experience with clinical trials applications (BLA, IND, IMPD)
· Broad knowledge of regulatory requirements for CMC (EU, US, ICH and other relevant guidelines)
· Broad knowledge of EU and US Pharmacopoeias and GMP regulations
This is a permanent role based in French part of Switzerland. This position offers excellent career progression and further projects in CMC regulatory affairs. Also the company supports the relocation process and offers additional benefits
Please send your CV to Beata.Klecz@mbaswitzerland.com