Career Category

Job Description

Global Regulatory Operations ? Regulatory Data & Analytics ? Senior Associate

Job Summary:

All, or a subset of the following:

Quality:

• Monitoring data quality/health, including collaboration with other internal functions to maintain planned submission and approval dates

Integrations:

• Updating the Regulatory Submissions and Document Information Management System (RSDIMS)

Analytics:

• Metrics compilation and analysis
• Liaison with internal customers to improve efficiencies within RDA and other functional areas
• Manages requests within the Regulatory Intake System to comply with data management of a GMP system

Key Activities:

• Maintain Regulatory document management and tracking systems.
• Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence
• Responsible for maintaining the on-site hard copy Regulatory archive and overseeing incoming/outgoing off-site Regulatory document storage.
• Point of contact between Regulatory Representatives/CMC and publishing teams.
• Manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions.
• Ensuring Regulatory compliance with SOPs and Regulatory authorities
• Provide training, mentoring and support to RDA team members and other functional areas, including vendors.
• Collaboration with external partners/outsourced CROs
• Run 1572 forms for FDA submission.

Knowledge and Skills:

• Working in teams
• Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
• Complex understanding of the Veeva Vault system
• Good written and verbal communication skills
• Detail oriented
• Independent time management and prioritization skills
• Work efficiently with little support and minimal to no supervision
• Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
• Critical thinking skills
• Appropriate software skills as required

Education & Experience (Basic):

Master?s degree

OR

Bachelor?s degree and 2 years of directly related experience

OR

Associate?s degree and 6 years of directly related experience

Or

High school diploma / GED and 8 years of directly related experience

Education & Experience (Preferred)

• Industry experience
• Experience in an operationally-focused role within Regulatory Affairs

.