Job
Description

1. Coordinate
regulatory projects between internal departments, manufacturing
facilities, regulatory teams, and external regulatory
pharmacists, consultants, and agents.

2. Work closely
with Quality Assurance (QA), Quality Control (QC), Production,
R&D;, Packaging Development, and other manufacturing-related
departments to obtain required technical information and
documentation.

3. Review
regulatory observations, technical queries, and documentation
requests received from regulatory authorities, consultants,
distributors, and international partners.

4. Convert
regulatory and technical requirements into clear action points,
assign responsibilities, establish timelines, and follow up with
the relevant departments until completion.

5. Review
technical documents, including product specifications,
certificates of analysis, stability data, analytical methods,
validation documents, manufacturing information, artworks, and
GMP-related records.

6. Coordinate the
preparation and availability of dossiers, product samples,
reference standards, impurity standards,



working standards,
legalized documents, certificates, and other submission
requirements.

7. Identify
missing information, documentation discrepancies, technical
inconsistencies, and potential delays and coordinate with the
responsible departments to resolve them.

8. Prepare
qualified emails, meeting minutes, technical clarifications,
project updates, action lists, and status reports for internal
and international stakeholders.

9. Maintain
detailed trackers for product registrations, regulatory
observations, documentation status, samples, standards,
departmental responsibilities, and submission timelines.

10. Support
regulatory submissions, renewals, variations, deficiency
responses, and product-launch activities by ensuring that all
technical, analytical, and manufacturing inputs are complete and
provided within the required timelines.

Requirements
Requirements

1. Bachelor’s
degree in Phar

📌 JB 205 - Project Manager - Quality Assurance (Dehradun)
🏢 Rhydburg
📍 Dehradun