Regulatory Operations Manager

Job Specifications

• Job Title: Manager – Regulatory Operations
• Location: Dehradun, Uttarakhand
• Industry: Pharma Manufacturing Industry
• Experience: 5 – 12 Years
• CTC Range: 12.00 – 15.00 LPA
• Candidate’s Background: Candidates from reputed Pharma background with detailed knowledge of Reviewing Dossier and Regulatory operations activities.
• Educational Qualification: B.Pharma / M.Pharma.

Job Summary

• The Regulatory Operations Manager will be responsible for reviewing, compiling, publishing, submitting, and maintaining regulatory documentation (Dossier) for pharmaceutical products in compliance with applicable regulatory authority requirements and company procedures. The role involves coordination with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Medical Writing, and other cross-functional teams to ensure accurate and timely regulatory submissions.

Key Responsibilities

• Maintain regular communication with regulatory bodies to stay informed on the status of current submissions.
• Track and report changes in the regulatory landscape of targeted countries.
• Document and archive any changes to registration guidelines in target markets, ensuring proper records for future reference.
• Monitor and ensure internal processes and systems remain compliant with regulatory changes.
• Advise internal teams on how to implement regulatory updates into operational workflows.
• Analyze and manage queries related to regulatory submissions.
• Ensure that all queries are resolved in a structured and timely manner to maintain smooth submission processes.
• Continuously monitor regulatory developments to ensure compliance.
• Drive efforts to reduce the time to market for products by improving operational efficiency and reducing regulatory hurdles.
• Review the product life cycle post-registration to ensure ongoing compliance during manufacturing and distribution.
• Review and raise requests for dossiers and documentation as per regulatory plans.
• Share dossiers and documentation with clients, ensuring completeness and compliance.
• Review vendor documentation to ensure it meets regulatory standards and supports submissions.
• Supervise and manage the assigned team, providing guidance mentorship, and support to meet departmental goals.
• Foster a collaborative work environment to ensure the team’s success and continuous growth.

Interested candidates can fill below mentioned form

https://forms.gle/amEE3rmj4JvictVq9

Shortlisted candidates will get call from us soon

Regards

Nikita Lodha

Leed HR Services

Nikita@leedhrservices.com