Assistant Manager Regulatory Affairs Dehradun (India)

Prepare, review, and maintain regulatory submissions

and documentation in compliance with applicable regulatory guidelines.

Coordinate preparation of dossiers, variations,

renewals, amendments, and other regulatory submissions.

Review product documentation, specifications,

analytical data, stability data, and manufacturing

information for regulatory compliance.

Work closely with Quality Assurance, Quality

Control, R&D;, Production, and other cross-functional

teams for regulatory requirements.

Ensure regulatory documents are accurate, complete,

properly controlled, and submitted within defined timelines.

Support responses to regulatory queries,

deficiencies, observations, and requests for additional information.

Maintain regulatory databases, submission trackers,

licenses, certificates, approvals, and related records.

Review and assess QA-related documents, deviations,

CAPA, change controls, SOPs, and quality documentation for

their regulatory impact.

Monitor changes in regulatory guidelines and assess

their impact on existing products, processes, and documentation.

Support regulatory audits and inspections by

coordinating required documents, responses, and

compliance-related activities.

Requirements

Bachelor’s

degree in Pharmacy, Pharmaceutical Sciences, or a related

discipline is mandatory.

Minimum five

years of experience in Quality Assurance, can consider

candidates who have worked on manufacturing units and has

handled market complaints.

Robust

knowledge of finished product specifications, analytical

methods, and pharmaceutical laboratory testing

practices.

Working

understanding of analytical method validation principles and

regulatory requirements for laboratory testing.

Ability to

review analytical documentation and technical manufacturing

data and coordinate effectively with R&D;, QC, QA, and

regulatory teams.

Advantages

Option to work

from home or from office depending on operational

requirements.

Exposure to

regulatory operations and pharmaceutical product submission

processes across multiple markets.

Chance to

work closely with manufacturing, analytical laboratories, and

regulatory teams.