Description
Key features--To ensure regulatory compliance, with a focus on patient safety
- As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)
- Advising the GRT on regional considerations in developing strategy
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- May manage one or more regional leads or support roles
- May participate as a member of:
Global Regulatory Team (GRT)
Global Development Team (GDT)
Clinical Study Team (CST)
Label Working Group (LWG)
Regional Teams (e.g. IMT, IBT, NAMT)
Health Authority Interactions-
1. Act as a contact with national regulatory agencies in fulfilling local obligations by product assignment
2. Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
3. Under general supervision participates in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy-includes contingency regulatory planning/risk assessment
Additional Responsibilities -
-Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
- Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provides content guidance for regional regulatory documents and meetings in accordance with GRT strategy
- Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan)
- Manages in the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Supports regional label negotiation activities
- Under general supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
- Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
To find out more about Real please visit www.realstaffing.com