Hobson Prior are currently recruiting for a Regulatory Affairs Manager on a permanent basis, to join a world-wide pharmaceutical company based in Switzerland, who focus on providing pioneering medical solutions to improve the quality of people's lives.

Job Responsibilities:

• Support the RA core-team representative in the classification and application of the regulatory strategy for projects.
• Lead the RA core-team representative in coordinating the preparation of submissions, such as: INDs/CTAs, Briefing Documents to support meetings with Health Authorities, PIP/PSP, Fast Track/ Breakthrough Designation/PRIME, etc.
• Manage regulatory vendors in charge of publishing and performing local submissions.
• Review and contribute to the approval of Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, DSURs, and other documents of regulatory relevance.
• Maintain knowledge of the global competitive and regulatory landscapes.
• In collaboration with the Quality department, contribute to the continuous assessment of internal processes, increase opportunities for improvement while ensuring compliance to applicable regulations.

Key Skills:

• Must have the ability to work independently and be result driven. However also have the ability to work with a team and have the ability to influence outcomes.
• Excellent organisational, communication and time management skills.
• Excellent written and communication skills in English.

Requirements:

• 6-10 years pharmaceutical industry experience, including minimum 4 years in regulatory affairs. Global experience essential.
• Bachelor's degree in Health/life-sciences; a higher degree is an asset.
• Demonstrated regulatory knowledge and experience in early phases of development. Experience in Phase III-IV development, as well as in antibacterial or oncology drug development is preferred.

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.