Executive-Regulatory Affairs

Dear Candidate

Greetings from Medley Pharmaceuticals Ltd,

We have an urgent job opening for the position of Executive in Regulatory Affairs department at our Mumbai corporate office.

Interested candidate can share their CV's on [email removed]

Job Description

Experince : 3 to 5 Years
Designation : Executive

Location : Mumbai- HO

Department: Regulatory Affairs for UK Market

CTC- 5.0 LPA to 7.0 LPA

Note- Min 3 years of experience require for UK Market only.

Scope of Work:
To support regulatory submissions, product registrations, preparation and maintenance of regulatory documentation, and coordination with internal departments to ensure compliance with applicable pharmaceutical regulatory requirements for formulation products.

Key Performance Indicator:

1. Regulatory dossier preparation and submission

• Prepare, compile, review, and maintain regulatory dossiers for pharmaceutical formulation products for UK Market
• Support preparation of CTD, eCTD, ACTD, and country-specific dossiers, as applicable.
• Coordinate collection of technical documents required for new product registration, product approvals, variations, and renewals.
• Ensure dossier completeness, consistency, accuracy, and submission within defined timelines.
• Prepare submission checklists, application forms, cover letters, and supporting documents.

2. Regulatory documentation and review

• Collect and review technical documents from Quality Assurance (QA), Quality Control (QC), R&D, Production, Packaging, and other concerned departments.
• Review documents such as:
• Product Development Reports (PDRs).
• Master Formula Records (MFRs) and Batch Manufacturing Records (BMRs), where applicable.
• Specifications and Certificates of Analysis (COAs).
• Analytical Method Validation (AMV) reports.
• Process validation reports.
• Stability study data and reports.
• Manufacturing process and product composition details.
• Ensure regulatory documents are current, properly approved, and maintained as per document-control procedures.

3. Regulatory submissions and product registration

• Prepare and coordinate regulatory applications for domestic and/or international markets, according to assigned responsibilities.
• Support submissions to CDSCO, State Drug Control Authorities, and international regulatory agencies, as applicable.
• Coordinate product registration, manufacturing permissions, site registration, and other regulatory approvals.
• Track application status and follow up on pending approvals and documentation requirements.

4. Product labelling and artwork review

• Review labels, cartons, package inserts, and other packaging artwork for regulatory compliance.
• Verify product name, composition, strength, dosage form, pack size, storage conditions, warnings, and other required particulars.
• Coordinate artwork corrections with Packaging Development, Quality Assurance, Marketing, and other concerned departments.
• Ensure approved artwork is consistent with the applicable regulatory approval and market requirements.

5. Regulatory queries and correspondence

• Assist in preparing responses to regulatory authority queries and deficiency letters.
• Coordinate with concerned departments to obtain supporting data and documents.
• Maintain records of regulatory correspondence, submission acknowledgements, and approval letters.
• Follow up with regulatory authorities, consultants, distributors, or international agents, as applicable.

6. Post-approval change management

• Support regulatory assessment of changes related to formulation, manufacturing process, manufacturing site, specifications, analytical methods, packaging, and shelf life.
• Coordinate with QA, QC, R&D, and Production to identify the regulatory documentation required for proposed changes.
• Assist in preparing variation applications and maintaining product registration records.
• Track renewal dates and ensure timely submission of renewal applications.

7. Regulatory compliance and record maintenance

• Monitor applicable regulatory guidelines and communicate relevant updates to the reporting manager.
• Maintain regulatory databases, product registration trackers, approval records, and submission archives.
• Ensure compliance with applicable regulatory requirements, internal SOPs, and document-control procedures.
• Support regulatory audits, inspections, and customer audits by providing relevant documents when required.

Competencies:

• Knowledge of pharmaceutical formulation products, including tablets, capsules, liquids, and topical preparations.
• Understanding of CTD/eCTD/ACTD dossier structure and regulatory submission processes.
• Familiarity with applicable CDSCO and State Drug Control requirements or relevant international market regulations.
• Good technical documentation, proofreading, and data-review skills.

Required Qualification:

• B. Pharm / M. Pharm / M.Sc. in a relevant pharmaceutical or life-science discipline.

Required Experience:

• Typically, 3-5 years in regulatory affairs for UK Market, preferably in a formulation pharmaceutical company.

Thanks

HR Department