JB-008 – Senior Executive, Regulatory Operations
Rhydburg
- Location
- Dehradun, Uttarakhand, India
- Job type
- Full-time
About the role
Rhydburg
Website:
rplglobal.com
Job details:
Job Description
- Develop and execute regulatory submission plans for assigned products and markets.
- Manage end-to-end lifecycle of regulatory submissions including filings, responses, and approvals.
- Coordinate with regulatory authorities and local agents for submission follow-ups and clarifications.
- Track, update, and maintain records of submissions, responses, and regulatory approvals.
- Liaise with Quality Assurance, R&D, and Production teams for timely and accurate documentation.
- Support preparation, compilation, and review of dossiers, variations, and renewal submissions.
- Assist in drafting and coordinating responses to regulatory queries and deficiencies.
- Monitor submission timelines and escalate delays or gaps to the Assistant Manager.
- Ensure regulatory documentation complies with prescribed formats and authority requirements.
- Execute approved regulatory plans without deviation from defined strategy and timelines.
Requirements
Requirements
- Bachelor’s or Master’s degree in Pharmacy Science or related discipline is mandatory.
- Minimum three years experience in pharmaceutical finished formulation industry.
- Experience coordinating with regulatory authorities, agents, and internal stakeholders.
- Working knowledge of regulatory submission processes, formats, and lifecycle management.
- Strong organizational skills with ability to manage multiple submissions simultaneously.
Benefits
Benefits
- Option to work from home or from office based on role requirements.
- Flexible working schedule with outcome-driven performance expectations.
- Exposure to multi-country regulatory submissions and approval lifecycle activities.
Click on Apply to know more.
This page is fully interactive when JavaScript is enabled. Please enable JavaScript to apply or browse related roles.