Position: Trainee Assistant

Department: Regulatory Affairs

Location: Mahape, Navi Mumbai

About Celogen:

Celogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter/manufacturer based in India. The company provides it products and services in multiple countries globally including West Africa, East Africa, South Asia, South East Asia, the Middle East, and South America & Europe.

Apart from promoting our branded products in the retail sector, we also participate in a number of global tenders in a number of countries. The team comprises of a group of first generation marketing expats and some of the best technocrats in the field. The company has four manufacturing bases in India, manufacturing a variety of products.

Position Summary:

We are looking for a motivated and detail-oriented Trainee Assistant - Regulatory Affairs to join our Regulatory Affairs team. This is an excellent chance for fresh graduates to gain hands-on experience in pharmaceutical regulatory documentation, dossier preparation, product registrations, and compliance with international regulatory requirements.

The trainee will work closely with senior regulatory professionals and gain practical exposure to the complete regulatory lifecycle for pharmaceutical products.

Key Responsibilities:

- Assist in the preparation, compilation, review, and submission of regulatory dossiers for domestic and international markets.
- Support the preparation and maintenance of CTD/eCTD documentation.
- Collect, organize, and maintain product-related technical and regulatory documents.




- Coordinate with internal departments such as Quality Assurance, Quality Control, Production, Packaging Development, Purchase, and International Marketing for regulatory documentation.
- Maintain regulatory databases, trackers, and document management systems.
- Assist in responding to regulatory authority queries and deficiency letters.
- Support product registration, renewal, variation, and post-approval change activities.
- Ensure all regulatory documents are complete, accurate, and submitted within timelines.
- Monitor document expiry dates and maintain updated records.
- Stay informed about changes in pharmaceutical regulatory guidelines and compliance requirements.
- Prepare reports and maintain proper filing of regulatory documents.
- Perform any additional responsibilities assigned by the Reporting Manager.

Educational Qualification

- B.Pharm or M.Pharm (Freshers are encouraged to apply)

Experience

- Freshers are welcome.
- Internship or project exposure in Regulatory Affairs will be an added advantage.

Required Skills

- Basic understanding of pharmaceutical regulatory processes.
- Knowledge of CTD/eCTD documentation (preferred).
- Familiarity with pharmaceutical manufacturing and quality systems.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint).
- Good documentation and record management skills.

Pay: ₹180,000.00 - ₹200,000.00 per year

Ability to commute/relocate

- Navi Mumbai, Maharashtra 400701: Reliably commute or planning to relocate before starting work (Required)

Education:
- Bachelor's (Required)

Work Location: In person

📌 Trainee Assistant - Regulatory Affairs (Navi Mumbai)
🏢 Celogen Pharma
📍 Navi Mumbai