Regulatory Affairs Manager (JP4591)

Location: Thousand Oaks, Ca
Date Posted: 08-08-2018
Job Title:  Regulatory Affairs Manager (JP4591)
Location: Thousand Oaks. Ca OR Remote
Type: Contract
Duration: Initial 7 months with likely extension
Business Unit: Global Regulatory Affairs
 
3Key Consulting Inc. is recruiting for a Global Regulatory Affairs Manager with 4 – 10 years of experience in managing global regulatory filing (from filing to approval) for a global, CA-based, bio-pharmaceutical company.
 
Top 3 Must Have Skill Sets:
  • Knowledge of FDA Regulations and IND, NDA, BLA submissions
  • FDA liaison experience with project managers
  • Familiarity with document publishing
 
Description:
The responsibilities of the (US) Regional Regulatory Manager are:
  • To develop and execute regional regulatory strategies and manage effective agency interactions
  • To advise the GRT on regional considerations in developing strategy
  • To ensure the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
  • 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
  • Represent regional regulatory affairs as a member of the GRT, Evidence Generation Team (EGT), Clinical Study Team (CST), Label Working Group (LWG), and/or Regional Teams
  • 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
  • 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
  • Manages in the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
  • Supports regional label negotiation activities
  • Obtains and maintains Clinical Trial Authorizations and Marketing
  • 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
  • Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations (e.g., Breakthrough therapy), Fast Track, compassionate use and pediatric plan)
  • Participate in the development, and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
  • Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
  • Works with line management to estimate the likelihood of regulatory success based on proposed strategies and communicates to GRT
  • Develop predictions for expectations and risks associated with outcomes by regulatory agencies
  • Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement
  • Evaluates and communicates impact of relevant regional regulations, guidance, current regulatory environment and competitor labelling
  • Participate in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy—includes contingency regulatory planning/risk assessment
     
Basic Qualifications:
Doctorate degree OR
Master’s degree and 2 years of Regulatory experience OR
Bachelor’s degree and 4 years of Regulatory experience OR
Associate’s degree and 10 years of Regulatory experience OR
High school diploma / GED and 12 years of Regulatory experience

Preferred Qualifications
  • MS Degree
  • 5+ years of Pharmaceutical and/or Biotech experience
  • 2+ years of Oncology experience
  • Experience 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
  • Team oriented
  • Strong 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
 
Day to Day Responsibilities:
Serve on the global regulatory team to support the US strategy and submissions for assigned projects
 
Employee Value Proposition:
This is an expansion project, good opportunity to learn Amgen products and portfolios. Gain experience in the oncology area.
 
Red Flags: Primarily CMC experience with no clinical regulatory experience
 
Interview Process:
1 phone screen and one onsite In-person interview
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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