CMC Regulatory Affairs Associate / Remote-Work

  • Pioneer Data Systems Inc
  • Newbury Park, Thousand Oaks, CA, USA
  • Aug 01, 2020
Full time Government

Job Description

Our client, a world leading Pharmaceutical Company in Thousand Oaks, CA is currently looking for a CMC Regulatory Affairs Associate / Remote-Workto join their expanding team.

Position Details:

Job Title: CMC Regulatory Affairs Associate / Remote-Work

Duration: 5 months contract, extendable up to 36 months

Location: Thousand Oaks, CA

Note:

Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.

You may participate in the company group medical insurance plan

Description:

Ideal candidate will be working remote until the site reopens.

Manager is open to non local candidates but must work PST hours

Bachelors Degree Minimum

5+ years of RA experience in Manufacturing, Testing, Change Control, Pharma or Biotech. Must understand the processes.



Job Requirements:

Responsibilities:

The CMC Site team is responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative.

The RA CMC Senior Associate will interface with global and regional CMC regulatory leads, site teams and supply chain for specific strategies or activities that impact a product or multiple products. The RA CMC Sr Associate will be responsible for varying levels of product support, including leading projects, based upon their experience level.

Day to Day Responsibilities:

Assessment of manufacturing, testing, and supplier change controls for regulatory reportability

Provide assessment of deviations for impact to product filings

Top 3 Must Have Skill Sets:

Biologics manufacturing or regulatory affairs CMC experience

Ability to prioritize, multi-task, and understand complex manufacturing and/or testing changes

Self-starter. Appropriate training materials will be provided, but onboarding and work will be remote with no micromanaging from supervisor.

Employee Value Proposition:

Exposure to different departments. Wide variety of processes, products & opportunity.