Associate Regulatory Affairs

• 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

• 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

• 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.

• 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.

• 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.

• 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.)

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