Sr Associate Regulatory Affairs
at Ronin Staffing

Date Posted: 10/7/2019

Job Description

HERE’S THE JOB DESCRIPTION:
Title:
Sr Associate Regulatory Affairs 
Pay: up to $38.00/hr; DOE
Location: Thousand Oaks, CA 91320
Duration: 1 year contract with possible extension                       

Description:

**Position is on site, regular hours, M-F**

**Ideal candidate**; Someone who has an educational background and/or experience in Regulatory Affairs. Someone who has either submitted to the FDA or understands FDA submissions.

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 Set:

  • Good communication skills - both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Ability to recognize and escalate potential issues

Job Snapshot

  • Employee Type: Contractor
  • Location: Thousand Oaks, CA
  • Job Type: Other
  • Experience: Not Specified
  • Date Posted: 10/7/2019

About Us

Founded in 1999 as a woman- and minority-owned IT staffing organization, Ronin Staffing has grown into a full-service staffing search firm that recruits and places qualified and quality candidates with expertise in a wide range of areas, including Engineering, Aerospace, Administration, Accounting/Financing, to name a few. We offer contract-only, contract-to-hire or direct-hire services to our clients and our contractors alike.

Our team of experienced, dynamic and tenacious recruiting specialists will provide you with the personal assistance you need to keep your career moving onward and upward. Whether you are looking for hourly, mid-management or executive level positions, you can be confident in our recruiters’ ability to match you with just the right assignments with just the right companies to suit your needs. Many members of our staff have backgrounds in the industries for which they now recruit, and Ronin has become one of the leaders in providing professionals to Fortune 100, 500, and 1000 companies.

We are proud to offer you a full line of services to help you to meet your career objectives, including resume assistance, human resources consulting, and expert guidance on professional interviewing techniques. We also offer direct deposit and a competitive benefits package.

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