Hobson Prior are currently working with a swiss based biopharmaceutical company who are seeking a Global Regulatory Affairs Senior Manager to join them on a permanent basis in Lausanne. You will be actively involved in supporting the development of innovative new medicines, including small molecules, biologics and/or radiopharmaceuticals.

Job Responsibilities:

• Accountable to support the RA core-team representative in the definition and implementation of the regulatory strategy for assigned projects.
• May as the RA core-project team representative for selected projects of less complexity.
• Lead independently or support the RA core-team representative in coordinating the timely preparation of several submissions, such as: INDs/CTAs, Briefing Documents to support meetings with Health Authorities in several jurisdictions, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation/PRIME, etc.
• Independently or in collaboration with the RA core-team representative, you will guide cross-functional teams in defining the best strategy for each submission, their content and the contribution of each team member to their preparation.
• Manage regulatory CROs in charge of publishing and performing local submissions.
• Represent Regulatory Affairs in several internal cross-functional teams, like Clinical Teams and Study Teams, etc.
• 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 partnership with the Quality Organization, contribute to the continuous assessment of internal processes, maximizing opportunities for improvement while ensuring compliance to applicable regulations.

Key Skills:

• Independent, result driven, team-oriented, agile individual with the ability to influence outcomes.
• Excellent organizational, communication and time management skills needed to manage multiple ongoing activities simultaneously.
• Must be able to innovate, analyze and solve critical problems with limited supervision.
• Strong written and communication skills in English (knowledge of French is beneficial but not a requirement).

Requirements:

• Bachelor's degree in Health/life-sciences; a higher degree is an asset.
• A minimum of 5-8 years pharmaceutical industry experience, including minimum 4 years in regulatory affairs. Global experience desired.
• 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, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.