Global Regulatory Affairs Senior Manager
An international research organisation is seeking to recruit a Global Regulatory Affairs Senior Manager to their office in Geneva. The company specialises in developing safe, effective, and affordable treatments for millions of people across the world being affected by neglected diseases, including paediatric HIV and hepatitis C. This is an exciting opportunity to work with a notable and prestigious organisation and significantly bolster a career in the regulatory field.
- Act as an in-house regulatory expert, advising and supporting the disease teams.
- Lead the preparatory activities including documentation (e.g. briefing package), writing, and compilation for interactions with regulatory authorities (eg. pre-IND, scientific advice, paediatric plans etc.) and may lead or co-lead face to face meetings.
- Provide regulatory support to disease teams on clinical trial requirements and review critical documents intended for submission to regulatory authorities such as IBs.
- Interact with internal and external stakeholders, consultants, partners, and regulatory authorities.
- Coordinate regulatory activities with pharmaceutical and other partners.
- Provide regulatory support to disease teams on clinical development plans.
- Support Head of Regulatory Affairs in Regulatory Intelligence related activities, sharing relevant updates.
- Support Head of Regulatory Affairs in other delegated tasks.
- Report to Head of Regulatory Affairs.
Skills and Requirements:
- Either an advanced post graduate degree, graduate degree with equivalent in experience to reach Master level, Pharmacy degree, or Ph.D. in relevant field.
- Minimum 8 years' regulatory affairs experience in pharmaceutical development with Senior role experience in medicine registration.
- Experience of managing registrations with different regulatory authorities.
- Experience with different regulatory authorities (stringent, National Regulatory Authorities).
- Proven ability to work effectively in a team environment and matrix structure, managing complex/virtual networks and partners.
- Experience of working in public and private sector is highly desirable.
- Professional experience as part of a regulatory agency would be useful.
- Experience in diseases is desirable.
- Degree/specialization in regulatory affairs.
- Proficiency in local languages desirable.
- 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.