Regulatory Affairs Manager- Development
Posted on Oct 10, 2020 by Michael Bailey Associates - Zurich
We have an exciting opportunity for a regulatory affairs manager to provide expertise and support to a product in the development stage.
- Support the Global Regulatory Lead for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant procedures and regional/local country regulations.
- planning, coordinating preparation and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
- Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
- Identify potential regulatory risks to the operational plan and propose options to mitigate risks.
- Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
- Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the Global Regulatory Scientist Lead.
- Delivers project assignments supporting the business eg representation on functional workstreams
- Ensure that appropriate, up-to-date records are maintained for compliance
- Assist in development of regulatory standards and SOPs
Education to a scientific degree
At least 5 years of experience in function as a regulatory affairs manager overseeing EU related projects
Experience in providing strategic and operational regulatory input and guidance
Knowledge and experience in handling regulatory submissions to agreed project targets.
Experience with MAA (CP), and review of paediatric plans
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.