Regulatory Affairs Manager
12 Month Contract
Uxbridge or Cambridge base - UK
This role will support one or more products from a regional regulatory perspective.
As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
The purpose of this role is:
To ensure that Amgen acquires and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products.
To ensure timely regulatory compliance with above approvals
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).
Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment
Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
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
Region Specific Activities EU:
Review and approve promotional and non-promotional materials for use in the region EM:
Manage the product lifecycle for individual countries per national agency requirements EM:
Work through the regional leads to manage distributor markets
Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the 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, conditional/accelerated approvals, compassionate use and pediatric plan)
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.
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
Required Knowledge and Skills
A minimum of 5 years of Regulatory Affairs experience
Regulatory Affairs experience concerning Clinical Trial Applications
Experience dealing with EMA - Centralised Procedure
Working with policies, procedures and SOP's
Knowledge of relevant legislation and regulations relating to medicinal products
Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
Knowledge of drug development
Cultural awareness and sensitivity to achieve results across both regional country and International borders.