Global Regulatory Operations Regulatory Data & Analytics Senior Associate
Job Summary :
All, or a subset of the following :
Monitoring data quality / health, including collaboration with other internal functions to maintain planned submission and approval dates
Updating the Regulatory Submissions and Document Information Management System (RSDIMS)
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
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) :
Bachelor’s degree and 2 years of directly related experience
Associate’s degree and 6 years of directly related experience
High school diploma / GED and 8 years of directly related experience
Education & Experience (Preferred)
Experience in an operationally-focused role within Regulatory Affairs