Senior Associate Regulatory Affairs (JP4596)

Location: Thousand Oaks, ca
Date Posted: 08-09-2018
Job Title:  Senior Associate Regulatory Affairs (JP4596)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Global Regulatory Affairs
Duration: 3 years
 
3Key Consulting Inc. is recruiting for an Associate Regulatory Affairs with 2 - 5 years’ experience in coordination and support of U.S. regulatory submissions, excellent communication skills, and ability to understand and communicate scientific and clinical information 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 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.
.
Collaboration Activities Include:
  • 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 Includes:
  • 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.
 
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 Activities Include:
  • 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.
 
Basic Qualifications:
Knowledge and Skills
  • 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.
  • 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.
 
Preferred Qualifications:
  • Experience working in an FDA regulated industry.
  • Science or clinical practice experience.
 
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 a number of 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.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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