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Associate Regulatory Affairs
Thousand Oaks,, CATop 3 Must Have Skill Sets:
Day to Day Responsibilities:
Additional Details:
The type of qualities/characteristics the hiring manager is looking for in candidates that will work best with their team:
Education background preferred for this role:
Top 3 qualities of the hiring manager's ideal candidate:
PAY RATE : $31/Hr on W2.
"This posting is for Contingent Worker, not an FTE"
- 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"