Navi Mumbai Maharashtra Pharma regulatory affairs Jobs – 8 Open Jobs Today

Senior Executive - Regulatory Affairs
CELOGEN PHARMA PVT LTD —Navi Mumbai, Maharashtra
- ₹4,20,000 - ₹5,28,000 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Product Safety and Regulatory Affairs Specialist
Croda International Plc —Navi Mumbai, Maharashtra
- Research
- Microsoft Office
- Communication skills
- Paid holidays
- Health insurance
Product Safety and Regulatory Affairs Specialist
Croda —Navi Mumbai, Maharashtra
- Research
- Microsoft Office
- Communication skills
- Paid holidays
- Health insurance
Senior Regulatory Affairs Executive
Zieva Farm Pvt. Ltd. —Andheri, Mumbai, Maharashtra
- ₹40,000 - ₹45,000 a month
- Full-time
- English
- Master's degree
- Bachelor's degree
- Flexible schedule
- Food provided
Quick apply
11d
Senior Officer Regulatory Affairs
Kilitch Drugs (India) —Navi Mumbai, Maharashtra
- B.Sc
- Master's degree
- Bachelor's degree
Asst. Manager / Manager – Regulatory Affairs
Client of Nitya Consulting —Andheri, Mumbai, Maharashtra
- ₹10,00,000 - ₹15,00,000 a year
- Full-time
- English
- Bachelor's degree
- In-person
Quick apply
Manager - Regulatory Affairs
PolyPeptide Group —Amarnath, Maharashtra
- Master's degree
- Bachelor's degree
- APIs
Medical Representative
Crypto Mize —Dive, Maharashtra
- Full-time
- Bachelor's degree
- Teaching experience
7d

Discover related jobs

Based on your search for pharma regulatory affairs jobs.

Executive Regulatory Affairs
Kilitch Drugs India —Navi Mumbai, Maharashtra
Reviewing of the relevant documents like DMF, Analytical reports, Specification, Process Validation Protocol, Report, BMR, COA, PDR, Stability data.
Quick apply
10d
Senior Executive - Regulatory Affairs
CELOGEN PHARMA PVT LTD —Navi Mumbai, Maharashtra
Good knowledge of international regulatory requirements, particularly EU and ROW markets. Support customer registrations and international tender documentation.
₹4,20,000 - ₹5,28,000 a year
Quick apply

I want to receive the latest job alerts for pharma regulatory affairs in navi mumbai maharashtra

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

pharma regulatory affairs jobs near navi mumbai maharashtra

Regulatory Affairs Specialist jobs in Navi Mumbai, Maharashtra

Operations Specialist jobs in Bengaluru, Karnataka

Product Support Specialist jobs in Pune, Maharashtra

Regulatory Affairs Specialist jobs in Maharashtra

Regulatory Affairs Specialist jobs in Ahmedabad, Gujarat

Medical Device Regulatory jobs in Remote

Regulatory Affairs Specialist jobs in Nehru Place, Delhi, Delhi

Regulatory Affairs,pharma Freshers jobs in Hyderabad, Telangana

Regulatory Affairs Specialist jobs in Mumbai, Maharashtra

Medical Affairs jobs in Chennai, Tamil Nadu

Regulatory Affairs Specialist jobs in Okhla Industrial Area Phase I, Delhi, Delhi

Hubspot Specialist jobs in Remote

Regulatory Affairs Specialist jobs in Jarod, Vadodara, Gujarat

Regulatory Affairs,fresher jobs in Hyderabad, Telangana

Regulatory Affairs jobs in Gandhinagar, Gujarat

Regulatory Affairs Specialist jobs in Kukatpally, Hyderabad, Telangana

Medical Billing,work From Home,payment Posting jobs in Ahmedabad, Gujarat

Medical Representative jobs in Orissa

Medical Representative jobs in Faizabad, Uttar Pradesh

Medical Representative jobs in Satara, Maharashtra

Senior Executive - Regulatory Affairs

CELOGEN PHARMA PVT LTD -
Navi Mumbai, Maharashtra

Quick apply

Job details

Full-time
₹4,20,000 - ₹5,28,000 a year

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Microsoft Outlook
Microsoft Office
Master's degree
Analysis skills
Quality assurance
Technical writing
Communication skills
Time management

Full job description

Position: Senior Executive
Location: Navi Mumbai (Mahape)
Department: Regulatory Affairs
Reporting To: Regulatory Affairs Manager

About Celogen

Celogen Pharma Pvt. Ltd. is a growing pharmaceutical manufacturing company engaged in the development and manufacturing of high-quality pharmaceutical formulations for domestic and international markets. The company operates advanced manufacturing facilities, including a dedicated hormone manufacturing unit in Gozaria, Gujarat, and additional manufacturing units in Ponda, Goa, and Somnath Road, Daman. With a strong focus on quality, compliance, hygiene, and operational excellence, Celogen Pharma is committed to delivering safe, effective, and affordable healthcare solutions while maintaining high standards across all its operations.

Position Summary

The Senior Executive - Regulatory Affairs will be responsible for preparing, reviewing, submitting, and maintaining technology transfer documents, regulatory dossiers and product registrations for pharmaceutical products across international markets throughout their product lifecycle (including handling of NODs). The role requires sound knowledge of regulatory requirements for Rest of World (ROW) markets, EU markets, CTD dossier preparation, and coordination with cross-functional teams to ensure timely regulatory submissions and compliance.

Key Responsibilities

1. Regulatory Submissions & Documentation

Prepare, compile, review, and submit regulatory dossiers for product registrations, renewals, variations, NODs, and tender submissions.
Ensure all product regulatory submission requirements are complete, accurate, and submitted within stipulated timelines.
Maintain product registration documents and database, submission trackers, regulatory databases, and product license records.
Maintain regulatory archives and ensure effective document control.

2. Regulatory Compliance & Strategy

Prepare, review and share technology transfer documents with sites for new product developments and/or site transfers
Monitor updates to international regulatory guidelines, legislation, and market requirements applicable to EU and ROW markets.
Interpret regulatory changes and communicate their impact to relevant stakeholders.
Provide regulatory support to cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Business Development.
Support regulatory strategies for new product registrations, lifecycle management, renewals, and post-approval variations.
Ensure compliance with applicable regulatory requirements and internal quality systems.

3. Regulatory Coordination & Communication

Coordinate with internal departments, manufacturing sites, customers, and regulatory authorities regarding submission requirements.
Prepare responses to regulatory queries, deficiency letters, and health authority communications.
Support customer registrations and international tender documentation.
Participate in internal audits, customer audits, and regulatory inspections.
Assist in regulatory due diligence activities and maintain effective communication with external stakeholders.
Assist in preparation of Standard Operating Procedures of Regulatory Affairs Department.

Education

M.Pharm from a recognized university.

Experience

4-5 years of experience in Regulatory Affairs within the pharmaceutical industry.
Hands-on experience in CTD dossier preparation and submissions for ROW markets.
Experience in product registrations, renewals, variations, and tender documentation.
Exposure to regulated market submissions (MHRA) will be an added advantage.

Skills & Competencies

Good knowledge of international regulatory requirements, particularly EU and ROW markets.
Working knowledge of ICH guidelines and CTD/eCTD documentation.
Excellent documentation and technical writing skills.
Strong analytical, organizational, and time management skills.
Ability to manage multiple submissions while meeting regulatory timelines.
Good communication and stakeholder coordination skills.
Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).

Pay: ₹420,000.00 - ₹528,000.00 per year

Application Question(s):

Will you be able to reliably commute to Mahape, Navi Mumbai, Maharashtra for this job?

Education:

Master's (Required)

Work Location: In person

Quick apply

Refine Your Search

pharma regulatory affairs jobs in navi mumbai maharashtra

Senior Executive - Regulatory Affairs

Product Safety and Regulatory Affairs Specialist

Product Safety and Regulatory Affairs Specialist

Senior Regulatory Affairs Executive

Senior Officer Regulatory Affairs

Asst. Manager / Manager – Regulatory Affairs

Manager - Regulatory Affairs

Medical Representative

Discover related jobs

I want to receive the latest job alerts for pharma regulatory affairs in navi mumbai maharashtra

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected