JB-1701 - Assistant Manager - Regulatory Affairs

Company : Rhydburg

Job Type : Full Time

Dehradun, India

Job Description - JB-1701 - Assistant Manager - Regulatory Affairs

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.
Strong
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.

Benefits

Option to work
from home or from office depending on operational
requirements.
Exposure to
regulatory operations and pharmaceutical product submission
processes across multiple markets.
Opportunity to
work closely with manufacturing, analytical laboratories, and
regulatory teams.

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JB-1701 - Assistant Manager - Regulatory Affairs

Job Description - JB-1701 - Assistant Manager - Regulatory Affairs

Requirements

Benefits

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