Job Position: Global Regulatory Affairs – Strategy Manager
Duration: Fulltime Permanent
Job Description:
Manager, Global Regulatory Strategy (GRS) will be a forward-facing role, representing GRS on project teams and communicating strategic options, issues and risks to a broad range of Stakeholders in an end-to-end pharmaceutical business model (R&D through commercial).
The candidate will have the opportunity to research, develop and implement regulatory strategies to facilitate global approval of new medicinal products. There will be an opportunity to contribute to a New Drug Application (NDA) submission, as well as other global registration submissions for a New Chemical Entity (NCE).
- The candidate in this position will be a key contributor to the planning, execution and assessment of product life cycle management activities and strategies - all with a global focus. The candidate will have the opportunity to lead interactions with the US Food and Drug Administration. Opportunity for interactions with ex-US Health Authorities is also possible within this role.
- The candidate will work with autonomy to provide advice on US regulatory clinical trial and marketing authorization requirements to the Regulatory Sub-team and the International Project Team (IPT). In addition, the candidate will have ownership of the preparation and submission of documents to Regulatory Authorities (Meeting Requests, Annual Reports, and Protocol Amendments etc.).
Responsibilities include but are not limited to:
1. Organizing resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed time frames. Providing regulatory support to project teams for assigned projects
2. Developing and implementing regulatory strategy for the assigned projects. Leading issue resolution of regulatory risks by identifying, escalating and monitoring issues
3. Contributing to the planning, execution, and assessment of product life cycle management activities and strategies
4. Contributing to, and implementing strategy for interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities
5. Contributing to the department-wide work-stream/initiatives, as assigned