(Senior) Manager Regulatory Affairs - Oncology
An oncology-focused biopharmaceutical company dedicated to improving the lives of patients with cancer is advertising a vacancy for a Senior Manager Regulatory Affairs - Oncology. Our team of passionate associates develops and commercialize safer and more effective supportive care agents and therapeutics. Based in Switzerland, this role is an exciting opportunity to work with a company that provides transformative therapies worldwide.
- Provide regulatory support for the projects assigned in collaboration with the regulatory lead.
- Represent regulatory in cross-functional discussion and present issues accordingly, where appropriate.
- Provide guidance to teams in support of regulatory activities for International markets.
- Participate in activities related to meetings with Health Authorities, including preparation and coordination of Briefing packages.
- Identify issues proactively that will impact programs and provide strategies to address them and communicate to the project team.
- Provide insight and guidance on implementation of regulations with respect to the preparation and submission of regulatory documentation, as well as the design of clinical trials.
- Create regulatory submission timelines in collaboration with cross functional teams.
- Provide input into regulatory development plan.
- Maintains regulatory compliance of OD, PIP, MAA Abilities Needed for Success.
Skills and Requirements:
- B.S. in a scientific discipline required.
- Must have 3+ years of relevant Pharma/. Biotech Regulatory Affairs experience.
- Ability to provide input to review core documents.
- Ability to identify and resolve regulatory issues.
- Knowledge of drug development and experience in registration procedures in EU/UK for MAA.
- Oncology experience desirable, Pharma experience necessary.
- Previous Exposure to International regulatory issues/Variations required.
- CV should reflect evidence of in-depth interaction with European Health Authorities, (ie. MHRA, EMA, PEI).
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Patrick Franke at +44 0207440063 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.