Director Regulatory Affairs - Global Regulatory Leader - Thousand Oaks, CA | Biospace
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Director Regulatory Affairs - Global Regulatory Leader

Amgen

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Location:
Thousand Oaks, CA
Posted Date:
12/9/2016
Position Type:
Full time
Job Code:
R-28866
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. This role is a product facing role that leads the Global Regulatory Team (GRT) in the Regulatory Affairs organization.

The purpose of this role is:

To lead several GRTs and other regulatory staff within Amgen's GRA department

To develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions

To provide regulatory expertise and guidance to product teams (eg, PST)

Responsibilities:

Develop and execute the global regulatory product strategy

Lead global regulatory team(s)

Represent GRA on the PST and other key commercialization governance bodies

Develop Global Regulatory Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan. Represent GRA on PST to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling

Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent

Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Lead the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)

Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)

Monitor and assess impact of relevant global regulations, guidance's, and current regulatory environment

Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy

Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood

Produce strategies that provide innovative alternatives which communicate the associated risks

Communicate Amgen's position consistently cross-functionally and across all documents

Interact with Global regulatory agency strategies, in collaboration with regional colleagues

Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)

Attend key regulatory agency meetings which could impact the global product strategy

Lead GRT to develop and execute team goals

Integrate regional regulatory representative input into GRT and regulatory plans

Represent GRA on key commercialization teams (e.g, PST, GDT, GST)

Represent Amgen GRA on external partnership teams at the PST level

Provide education and training on regulatory strategies and compliance issues to other functions

Ensure regulatory compliance for product

HJUS2016

Requirements

Basic Qualifications

Doctorate degree and 4 years of Regulatory experience

OR

Master's degree and 8 years of Regulatory experience

OR

Bachelor's degree and 10 years of Regulatory experience

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

Demonstrated ability to lead team

Strong communication skills - both oral and written

Ability to understand and communicate scientific/clinical information

Ability to anticipate and mitigate against future strategic issues & uncertainties

Ability to resolve conflicts and develop a course of action

Cultural awareness and sensitivity to achieve global results

Planning and organizing abilities

Managing multiple activities

Making complex decisions

Problem solving abilities

Setting priorities

Multi-disciplinary

Dealing with ambiguity

Organizational savvy

Action orientated

Conflict management

Building effective teams

Negotiation skills

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