Regulatory /Sr Regulatory Associate - Module 1- regulatory submission
- Syneos Health
- 1 - 4 years
- Mumbai
- 11 months ago
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Job Description
Essential Functions
For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:
- Interpret health authority approval letters and update registration data for marketed and investigational approvals.
- Ability to independently and accurately process the intake, archival and extraction of data from health authority correspondence including adding questions and commitments into tracking database, archiving documentation correctly, linking content to the correct submission and application data, and highlighting critical regulatory milestones.
- Responsible for ensuring data required for assigned program team is entered into the RIM system, is associated with the correct applications and is correct to build content plans and create registration records.
- Coordinates data review with data owners, in accordance with reporting timelines and due dates
- Highlights non-compliance and quality issues to the Regulatory Information Management team
- Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.
- Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.
- Attends client meetings as needed and builds client relationship in support of projects and deliverables.
- Systematically reviews Regulatory Associates or other Senior Associates work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.
- Assists in training and mentoring of team members depending upon project requirements.
- Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.
Qualifications - External
What were looking for
- Looking for 2 - 4 yrs of regulatory experience.
- Minimum 2yrs of Veeva vault and RIMS experience.
- BS/BA degree or equivalent practical experience.
- Experience in a work-related area preferred.
- Excellent interpersonal / communication skills.
- Advanced skills in Microsoft Office Applications.
- Strong analytical skills.
- Ability to work independently and to understand and carry out detailed instructions.
- Ability to interact with staff from multiple departments.
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
- Fluent in speaking, writing, and reading English.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: OtherRole Category: OtherRole: OtherEmployement Type: Full timeContact Details:
Company: Syneos HealthLocation(s): Mumbai
Keyskills: Veeva Vault Regulatory Submissions RIM
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