Hobson Prior are working with a world-wide healthcare organisation whose products and services are used to help care for patients who are critically ill. Our client is looking for a Regulatory CMC Senior Manager to join them on a permanent basis in Nyon, Switzerland.

Job Responsibilities:

• To manage submission CMC related documents for assigned assets.
• You will act as Regulatory Affairs CMC lead for early stage projects.
• To manage, prepare and confirm Quality regulatory documents which form the basis of worldwide submissions for clinical trials applications, BLA/MAA initial applications and Life Cycle Management.
• To lead the completion of the relevant Quality regulatory documents to allow timely submissions for the assigned products/countries and responses to questions from Authorities.
• To organise briefing books and provide support at Regulatory agencies meetings on Module 3 topics.
• You will ensure that the input in quality development includes the outcome of consultations and negotiations with Regulatory Authorities.
• Be able to interpret CMC data in regulatory CMC positioning, to create a comprehensive story line.
• You will be a business partner to the R&D team manages the CMC regulatory activities and CMC submission strategy of the records and submissions that best serve the biosimilars business needs and confirm compliance with the regulatory systems.
• To carry out regulatory review of Change Control Proposal, CMC protocols and reports, as well as other relevant CMC documents intended Keep up-to-date with the current regulatory environment and Quality area.
• Deputy Regulatory Affairs CMC Director where needed.
• To lead CMC Regulatory sub-teams on assigned projects.
• To carry out any other tasks as required by the function to achieve its mission and objectives.

Key Skills:

• Excellent spoken and written English. A second major language would be an advantage.
• Strong written and spoken communication skills.
• Excellent interpersonal skills.
• Good organizational and planning skills.
• Attention to details.
• Ability to work in teams.

Requirements:

• Degree in a Life Science or related discipline and possible higher degree.
• At least 5 years Regulatory Affairs CMC experience.
• Experience in managing international or regional regulatory submissions, IND/IMPD or variations.
• Experience in interaction with regulatory agency.
• Experience in biological product development.

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.