Global Regulatory Leader (JP4793)

Location: Thousand Oaks, ca
Date Posted: 10-01-2018
Job Title:  Global Regulatory Leader (JP4793)
Location: Thousand Oaks, CA./Remote
Employment Type:  Contract
Business Unit: Global Regulatory Affairs
Duration: 1+years (likely extensions)
 
3Key Consulting Inc. is recruiting for a Global Regulatory Leader with 4 – 10 years’ regulatory experience, 4 years of management experience; and major drug filing experience (from NDA/BLA filing to approval), management of communications between sponsors and regulatory authorities, oncology products, accelerated approval, breakthrough designation for a global, CA-based, bio-pharmaceutical company.
 
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
 
Top Must-Have Skill Sets:
  • Major filing experience as evidenced by taking an NDA or BLA from filing to approval.
  • Responsible for meaningful interactions between sponsors and regulatory authorities.
  • Has filing experience with USIND or EX US CTA with breakthrough resignation experience and fast track experience.
  • Prior interactions with the FDA in respect to oncology products, accelerated approval, breakthrough designation.
 
Day to Day Responsibilities
Will be articulating regulatory strategy, mitigation plans and accountability for US filings to achieve approval.
 
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:
  • Contemporary recent regulatory oncology experience.
  • 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
 
Why This Position Is Open:
Planned project strive for 5 initiative.
 
Employee Value Proposition:
Unprecedented early development products. Over 20 assets that could culminate to 5 approvals by 2023.
 
Red Flags:
  • No US or EU experience.
  • Not able to jump in and lead filing effort.
  • No experience previously serving as regulatory lead. Not willing to travel to Thousand Oaks, CA on a monthly basis.
 
Interview process:
30 minute phone screen to in person interview.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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