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Associate Regulatory Affairs

Thousand Oaks,, CA
Top 3 Must Have Skill Sets:   
  • Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance, including familiarity with US Certificate of Pharmaceutical Product (CPP) process.
  • Basic understanding of the Veeva RIM Vault system
  • Good written and verbal communication skills
  • Independent time management and prioritization skills and detail oriented
  • Critical thinking skills

Day to Day Responsibilities:  
  • Maintain Regulatory document management and tracking systems
  • Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence
  • Responsible for maintaining the on-site US Certificate of Pharmaceutical Product (CPP) responsibilities, as well as hard copy pickup at company and mailings.
  • Point of contact between Regulatory Representatives/CMC and publishing teams
  • Ensuring Regulatory compliance with SOPs and Regulatory authorities
  • Provide support to RDA team members and other functional areas, including vendors
  • Collaboration with external partners/outsourced CROs
  • Responsible for creating, running, and analyzing report data for potential Veeva RIM system clean-up

Additional Details:
  • This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works regular hours (7a-4p or 8am-5p etc).
  • However, would like someone who could be flexible and is able to shift their hours to start/end later, if needed, to work within the PST time zone.
  • To clarify, this would not be on a regular basis, this is just if coverage is needed for urgent tasks within the PST time zone.

The type of qualities/characteristics the hiring manager is looking for in candidates that will work best with their team:
  •  Works well collaboratively, as there is a lot of teamwork involved in what we do.
  •  Detail oriented, to be able to monitor data quality.
  •  Comfortable learning new systems/processes. Someone who is able to follow instructions/guides, since we work in a framework based on rules/compliance.

Education background preferred for this role:
  •  Science/Technology-based degrees are preferred OR industry-specific experience.
  •  If the candidate has experience in performing our team’s tasks and would be able to do this job, the type of degree would not necessarily matter.

Top 3 qualities of the hiring manager's ideal candidate:
  •  Good communication skills (verbal & written), resourceful critical thinker, detailed.
  •  (Overall, we’d need someone who understands the importance of details, since we work so much with monitoring Data Quality and someone who is able to communicate clearly with internal and external teams.
  •  Once training is completed, this individual must then understand how to utilize the tools provided to complete needed tasks, which requires resourcefulness and critical thinking skills.)

PAY RATE : $31/Hr on W2.

"This posting is for Contingent Worker, not an FTE"


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