Hobson Prior are looking for a Head Regulatory Affairs CMC to join a fantastic pharmaceutical organisation on a permanent basis located in Geneva. Our client is focused on creating products and offering services that are used within the therapy and care of those who are chronically ill.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will handle, monitor and evolve the members of the regulatory affairs CMC team.
• Trains regulatory professionals in all aspects of regulatory affairs biosimilars in assistance of product development.
• Serve as a representative for the regulatory affairs CMC division at cross functional or intercompany committees.
• You will own the general regulatory affairs CMC tactic for biosimilar projects.
• Offer international guidance concerning management of proposal CMC connected papers and CMC regulatory data for biosimilars.
• The ideal candidate might serve as a RA CMC lead for development projects.
• Guarantee that for every manufacturing change control proposal (CCP) the implications have been considered and justify the execution.
• Any other assigned duties.

Key Skills:

• An organised individual who can plan and prioritise workload.
• Capable of thinking tactically.
• Communication skills both verbally and in writing.
• Interpersonal abilities.

Requirements:

• At least 15 years of experience in a pharmaceutical field of which at least 10 of those years in global regulatory oriented around CMC in Biologics.
• Familiarity in handling a full initial marketing application proposal or IMPD/INDs.
• Acquaintance with preparing and organising regulatory method plans.
• Prior involvement in engaging with regulatory agency meetings for the major agencies such as EMA, FDA, etc.
• Former involvement in analytics or drug substance process development for new biological entities.
• Acquaintance with the development of new biologicals or biosimilars.
• Fluency in the English language with knowledge in another language.
• Comprehension of regulatory affairs partaking in pharma organisations.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.