Senior Associate Regulatory Affairs (JP4954

Location: Thousand Oaks, ca
Date Posted: 11-01-2018
Job Title:  Senior Associate Regulatory Affairs (JP4954)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Global Regulatory Affairs
Duration: 3 years
 
3Key Consulting Inc. is recruiting for a Senior Associate Regulatory Affairs with 2+ years’ experience regulatory affairs with an MS Degree in RA or Pharm.D.for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
Global Regulatory Affairs provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules.
 
This Role is Responsible for:
  • Local coordination and execution of US regulatory submissions in compliance with corporate standards and local regulatory requirements.
  • Management and execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions.
  • Coordination and execution of Regulatory Affairs processes and deliverables in the local office.
 
US Specific Activities
  • Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
  • Contribute to and execute the filing plan for their country where applicable.
  • Review source text for country labeling.
  • Review promotion and non-promotion materials.
  • Maintain an awareness of & ensure local management are kept up to date on new & developing local legislation & regulatory policy.
  • Disseminate relevant information to team(s) as appropriate.
  • Participate in local regulatory process improvements initiatives.
  • Assist locally in Healthcare Compliance activities where applicable.
  • Coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies.
  • Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
 
Collaboration
  • Collate, distribute and review Regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis.
  • Partner where required with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.
 
HA Interaction
  • Under general supervision participates in regulatory activities to ensure effective local agency interactions.
  • Act as a contact where appropriate with regulatory agencies in fulfilling local obligations by product assignment.
 
Knowledge & Skills
  • Good communication skills - both oral and written.
  • Ability to understand and communicate scientific/clinical information.
  • Organizational skills.
  • Working in a regulated environment.
  • Ability to recognize and escalate potential issues.
  • Document management and archiving practices.
  • Attention to Detail.
 
Competencies
  • Planning and organizing.
  • Managing multiple activities.
  • Setting priorities.
  • Action orientated.
  • Working in teams.
  • Written Communications.
  • Listening skills.
 
Education & Experience (Basic)
 
Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum,
OR
Bachelor’s degree in a science discipline (biology, life science, health science) and 2 years of directly related experience
 
Education & Experience (Preferred)
Regulated industry, science or clinical practice experience
 
Top Must-Have Skill Sets:
  • Good communication skills - both oral and written.
  • Ability to understand and communicate scientific/clinical information.
  • Organizational skills MS in Regulatory Science or PharmD strongly preferred.
 
Day to Day Responsibilities
Regional-specific activities include:
  • Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
  • Contribute to and execute the filing plan for their country where applicable.
  • Review source text for country labeling.
  • Review promotion and non-promotion materials.
  • Maintain an awareness of & ensure local management are kept up to date on new & developing local legislation & regulatory policy.
  • Disseminate relevant information to team(s) as appropriate.
  • Participate in local regulatory process improvements initiatives.
  • Assist locally in Healthcare Compliance activities where applicable.
  • Coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies.
  • Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
  • Coordinating translation for local Regulatory submission. Collaboration.
  • Collate, distribute and review Regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis.
  • Partner where required with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all.
 
Why This Position Is Open:
We are opening this position to help support our need for increased support in US Regulatory Affairs Oncology, due to our large, fast paced Oncology Portfolio.
 
Employee Value Proposition:
Amgen has an exciting, diverse, and burgeoning oncology portfolio. This vast portfolio contains several products progressing towards registration development programs. As a result, our oncology teams are seeking highly talented individuals with oncology experience from across the spectrum of product types to meet the rapidly evolving needs of the portfolio.
 
Red Flags:
Lack of substantial time in role in previous positions (i.e. jumping between jobs quickly)
 
Interview process:
Phone screen followed by a face to face 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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