Regulatory Affairs Manager
An exciting opportunity for a Regulatory Affairs Manager has arisen at an oncology-focused biopharmaceutical company dedicated to improving the lives of patients with cancer. The organisation's team of passionate associates develops and commercialize safer and more effective supportive care agents and therapeutics. This position will be in the company's Swiss office.
- Provide regulatory support for the projects assigned in collaboration with the regulatory lead.
- Support submissions, from planning to review - including scientific advice meeting packages, MAA, amendments, variations, annual reports etc..
- 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.
Skills and Requirements:
- B.S. in a scientific discipline required
- Minimum 3-5 years of relevant Pharma/Biotech Regulatory Affairs experience.
- Knowledge of drug development and of the registration procedures in EU/UK for MA.
- Oncology experience desirable.
- Previous Exposure to International regulatory issues a plus.
- CV should reflect evidence of in depth experience with 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 Megan Lockey at +44 203 854 2627 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.