Regulatory Affairs Manager – Regional Regulatory Lead – Intercontinental

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-31029
The group's purpose is to facilitate patient access to Amgen products in Intercontinental countries through executing on our Intercontinental filing plan; providing strategic regional regulatory guidance on regional regulatory mechanisms to optimize product development and approvals; aligning with key cross-functional partners; integrating into Amgen's commercialization process, and continuously improving our processes and developing our talent.
To ensure that Amgen 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
This role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)
This role is accountable for:
Executing the approved regional strategy for assigned programs
Representing the region
This role is 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 participate as a member of:
Global Regulatory Team (GRT)
Global Development Team (GDT)
Clinical Study Team (CST)
Label Working Group (LWG)
Regional Teams
Strategy and Execution
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
Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
Leads development of regional regulatory documents and meetings in accordance with GRT strategy
Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan)
Directs 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
Manages regional label negotiation activities
With minimal 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
Key Activities
Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
Communicates regulatory strategies as appropriate such that expectations are understood
Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management
Develop predictions for expectations and risks associated with outcomes by regulatory agencies
Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)
Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations
Communicate and ensure alignment of regional management before GRT strategy decisions
Partner with regional management and peers to ensure consistency in procedures and agency interactions
Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products
Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement
Evaluates and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labeling
Health Authority Interactions
Act as contact and create relationships with agency staff on specific product assignment
Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant senior management
Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy-includes contingency regulatory planning/risk assessment
Region Specific Activities
US: Advises and supports promotion group regarding applicability of data for product communication in the US
EU: Review and approve promotional and non-promotional materials for use in international region
APAC, LACAN, EEMEA: Lead the product lifecycle for individual countries per national agency requirements
APAC, LACAN, EEMEA: Work through the regional leads to manage distributor markets
Supports communication/collaboration between direct reports who are regional leads and regional head for program issues requiring next level engagement
Provides managerial leadership and direction to assigned team allowing appropriate prioritization of resources to achieve goals
Basic Qualifications
Doctorate degree
Master's degree and 3 years of regulatory experience
Bachelor's degree and 5 years of regulatory experience
Associate's degree and 10 years of regulatory experience
High school diploma / GED and 12 years of regulatory experience
Preferred Qualifications
Bachelor's degree and in-depth regulatory experience related to IC region
Knowledge of IC countries legislation and regulations relating to medicinal products
Knowledge of drug development Scientific / Technical Excellence
Knowledge and Skills
Regulatory principles
Working with policies, procedures and SOP's
Knowledge of national legislation and regulations relating to medicinal products
Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals
Knowledge of drug development
Scientific / Technical Excellence
Team work
Communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues
Knowledge of and experience in regional regulatory environment in relevant product area and development stage
Understanding of regulatory activities and their touch points
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional country and International borders
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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