About this role

Job Description

- Prepare, review, and maintain regulatory
documents and submissions in accordance with applicable regulatory
guidelines and company procedures.
- Compile and coordinate regulatory
dossiers, applications, renewals, variations, amendments, and
other regulatory submissions.
- Review technical documents, product
specifications, analytical data, stability data, and manufacturing
information for regulatory compliance.
- Coordinate with Quality Assurance, R&D, Production, and other departments to
obtain regulatory information and documentation.
- Review QA documents such as deviations,
CAPA, change controls, SOPs, and batch-related documents for
regulatory requirements and impact.
- Prepare and coordinate responses to
regulatory queries, deficiencies, observations, and requests for
additional information.
- Maintain regulatory trackers, submission
records, approvals, licenses, certificates, and other regulatory documentation.
- Support regulatory audits and inspections
by preparing required documents and coordinating responses with
the QA and relevant departments.
- Monitor updates in regulatory guidelines
and evaluate their impact on products, processes, documentation,
and quality systems.
- Ensure timely completion of regulatory
activities while maintaining accuracy, compliance, proper
documentation, and data integrity.

Requirements

- Bachelor’s or
Master’s degree in Pharmacy is mandatory.
- Minimum three years
experience in QA or analytical validation roles.
- Hands-on experience
reviewing analytical method validation documentation.
- Should have good
communication skills.
- Strong analytical
data interpretation and technical documentation review
skills.

Benefits

- Remote working option
with defined review responsibilities.
- Flexible working
hours aligned to dossier and submission timelines.
- High technical
ownership without laboratory or shop-floor operations.