Regulatory Affairs CMC Senior Manager

Hobson Prior are currently working with a fantastic global pharmaceutical organisation who are seeking a Regulatory Affairs CMC Senior Manager to join them on a permanent basis in Switzerland. Our client focuses on providing ground-breaking medical solutions that improve the quality of many people's lives.

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

Key Responsibilities:

• In this role, you will be responsible for establishing and maintaining strong working relationships with partners and customers.
• You will actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
• Responsible for identifying content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
• Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
• Prepare CMC responses to health authority questions during development, registration and product lifecycle.
• Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
• Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).

Key Skills:

• Effective planning, organisational and interpersonal skills.
• Reasonable approach to risk assessment.
• Excellent written/spoken communication and negotiation skills.

Requirements:

• The ideal candidate will require a Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
• It would be desirable if the candidate has an Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
• Languages: Fluent English required (oral and written).
• Good skills in site (local) language desired (oral).
• Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
• Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
• Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
• Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
• Computer literacy.

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.