Post : Manager Regulatory Affairs

Location: Andheri (East), Mumbai

Experience: Minimum 2 years of experience at Manager level in a Pharmaceutical Company.

Working Days: Monday to Saturday (1st & 3rd Saturdays Off)

Working Hours: 9:00 AM to 5:30 PM

Role Overview:

We are looking for an experienced Regulatory Affairs Manager with strong knowledge of pharmaceutical regulatory requirements, documentation, compliance, product dossiers, artwork review, audits, and quality systems.

The candidate will be responsible for managing regulatory activities, ensuring compliance with applicable national and international guidelines, coordinating with cross-functional teams, and supporting regulatory submissions and inspections.

Key Responsibilities:

1. SOP Development & Review

- Develop, review, revise, and maintain Regulatory Affairs SOPs.
- Ensure SOPs are aligned with current regulatory requirements and internal quality standards.
- Coordinate with Quality Assurance and other departments for implementation and periodic review of SOPs.

2. Dossier Preparation & Regulatory Submissions

- Prepare, compile, review, and maintain product registration dossiers.
- Handle documentation according to CTD (Common Technical Document) and ACTD (ASEAN Common Technical Dossier) guidelines.
- Ensure completeness and accuracy of regulatory documentation before submission.
- Coordinate with internal departments for timely collection of technical and supporting documents.

3. Artwork Development & Review

- Review and approve product artworks, labels, cartons, package inserts, and other packaging materials from a regulatory perspective.




- Ensure artwork complies with approved product information and applicable regulatory requirements.
- Coordinate with packaging, marketing, QA, and other relevant teams for artwork development and revisions.

4. Regulatory Compliance & Audits

- Support and coordinate regulatory inspections and internal/external audits.
- Prepare regulatory documentation and records required during inspections.
- Ensure timely closure of regulatory observations and corrective actions in coordination with relevant departments.
- Maintain regulatory readiness and compliance documentation.

5. Medical Devices & Ophthalmic Products

- Handle regulatory documentation and compliance requirements related to Medical Devices and Ophthalmic products .
- Support product registrations, renewals, variations, and other regulatory activities as applicable.

6. API DMF Documentation

- Review and coordinate API Drug Master File (DMF) documentation.
- Liaise with API manufacturers/vendors for required regulatory and technical documents.
- Ensure API documentation meets dossier and regulatory submission requirements.

7. Quality Assurance & Regulatory Coordination





- Work closely with the Quality Assurance team to ensure regulatory and quality compliance.
- Support change controls, deviations, CAPA, document control, and other quality-related activities wherever regulatory input is required.
- Ensure regulatory commitments are properly communicated and implemented across concerned departments.

8. FDA / ISO Compliance

- Maintain awareness of applicable FDA and ISO requirements .
- Ensure relevant documentation and processes comply with applicable regulatory and quality standards.
- Monitor regulatory updates and communicate changes that may impact products or processes.

9. Team Management

- Manage and guide the Regulatory Affairs team in day-to-day activities.
- Allocate responsibilities, review work, and ensure timely completion of regulatory deliverables.
- Coordinate with QA, QC, Production, R&D;, Purchase, Packaging, Marketing, and other departments as required.

Desired Candidate Profile:
- B. Pharm / Postgraduate qualification in Regulatory Affairs.
- Minimum 2 years of experience working at Manager level in a pharmaceutical company .
- Strong hands-on experience in SOPs, dossier preparation, CTD/ACTD, artwork review, inspections/audits, API DMF, and Quality Assurance coordination .
- Positive understanding of FDA, ISO, and pharmaceutical regulatory requirements .
- Strong documentation, analytical, communication, and coordination skills.
- Previous experience in team handling/management is desirable.
- Ability to manage multiple regulatory activities and deadlines independently.

Call or Whatsapp : (phone hidden)

📌 Manager - Regulatory Affairs (8LPA )-Andheri (Mumbai)
🏢 Indics Solution
📍 Mumbai