Regulatory Affairs Manager II

Thousand Oaks  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

Key Features -
-To ensure that Regulatory team acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products
- 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)
Responsible for:
- 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

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

Strategy and Execution -
1. 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.
2. Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
3. Provides content guidance for regional regulatory documents and meetings in accordance with GRT strategy
4. 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)
5. Manages in the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
6. Supports regional label negotiation activities
7. Under general supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
8. Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives

Education -

- Applications with s Doctorate Degree, Master's degree or Bachelor's degree in a related field will be highly considered.

To find out more about Real please visit www.realstaffing.com
Start date
01/2014
Duration
6 Months
From
Real Staffing
Published at
23.01.2014
Project ID:
654437
Contract type
Freelance
To apply to this project you must log in.
Register