Location
Secunderabad | India
Job description
Division
Global Drug Development / Global Regulatory Sciences / Global Regulatory Strategic Operations / Regulatory Information and Submission Management
Functional Area Description
Regulatory Information and Submission Management is an organization that delivers Health Authority submissions and product data to support the BMS portfolio and sets the strategic business direction and related processes oversight for GRS systems.
Position Summary
- Should be pulled from the appropriate Job Description data in Workday, appropriate source per department, or a contractor agreement.
- Several top-line sentences in plain text, focused on key accountabilities or duties.
- Ideally no more than 75 words.
- Avoid internal jargon or acronyms.
The Specialist supports the planning, organization, and review of routine submissions for clinical, nonclinical, chemistry, manufacturing and controls (CMC) and regulatory.
Position Responsibilities
- Should be pulled from the appropriate Job Description data in Workday, appropriate source per department or a contractor agreement.
- Typically 5-9 bullet points; each describing a distinct and primary responsibility of the role.
- Avoid generic comments such as works well with others , etc
- Tracks, collects and reviews all components for routine submissions to Health Authorities
- Interacts with responsible parties for quality submission documents for routine submissions
- Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision
- Prepare Cover Letter, FDA Forms and submission content plan for routine submissions
- Perform submission verification on published submissions to confirm eCTD compliant
- Update Verity with US planned submissions and update entries with submitted submissions
- Participates in submisison team meeting as applicable
- Coordinate non-eCTD submissions with ISL Intercon Team
- Other miscellaneous regulatory operational activities as needed
Degree Requirements
- Required degrees, certifications, and/or licensure relevant to role.
- BA/BS degree, science / technology field preferred
Experience Requirements
- Minimum number of years of relevant experience expected.
- 0-2 years pharmaceutical experience
Key Competency Requirements
- Foundational knowledge of global regulatory practices, electronic submission guidelines and requirements
- Ability to communicate questions and issues as they arise with possible solution
- Effective written and verbal communication skills
- Works with supervision
- Ability to prioritize and strong attention to detail
- Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, eCTD viewers and web based applications) and be technically savvy with such systems.
Travel Required (nature and frequency) - 5%
Job tags
Salary
