Regulatory Affairs Specialist

3 days ago

Navi Mumbai, Maharashtra, India CELOGEN PHARMA PVT LTD Full time ₹ 2,00,000 - ₹ 4,00,000 per year

Company Overview

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, 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

The Regulatory Affairs Specialist will be responsible for preparing, submitting, and maintaining regulatory applications for pharmaceutical products throughout their lifecycle in designated markets. This role requires a detail-oriented, proactive professional with a strong understanding of global regulatory guidelines (e.g., ROW Markets, ICH; Knowledge of FDA and EMA Requirements is a plus).

Key Responsibilities

1. Regulatory Submissions & Documentation

  • Prepare, coordinate, and review regulatory submissions, including dossiers, NODs and tender submissions
  • Manage the assembly and quality control of regulatory documents in CTD format
  • Ensure all submissions are accurate, complete, and submitted within regulatory timelines.
  • Maintain and update regulatory files and databases (e.g., submission trackers, product licenses) to ensure current and historical data integrity.
  • Prepare Technology Transfer Documentation

2. Compliance and Strategy

  • Monitor and interpret new and evolving regulatory guidelines, legislation, and industry standards, and communicate their impact to relevant internal stakeholders.
  • Provide regulatory input and guidance to cross-functional teams (e.g., R&D, Clinical, Quality, Manufacturing) to ensure studies and processes are compliant.
  • Support the development and implementation of regulatory strategies for new product development and lifecycle management.

3. Communication and Interaction

  • Act as a regulatory point-of-contact for internal teams and external stakeholders.
  • Coordinate and prepare responses to inquiries and deficiencies from health authorities
  • Participate in internal and external audits and inspections as the Regulatory Affairs representative.

Qualifications

Education

  • Bachelor's degree in Pharmacy
  • Master's Degree in Regulatory Affairs is a plus

Experience

  • Specialist Level: 3-5 years of experience in Regulatory Affairs within the pharmaceutical industry

Skills & Competencies

· Knowledge: Proven working knowledge of global regulatory requirements (e.g., ROW Markets, ICH; Knowledge of FDA and EMA Requirements is a plus).

· Soft Skills: Exceptional attention to detail, strong organizational skills, and excellent written and verbal communication skills.

Application Process

Interested candidates are invited to submit their resume and cover letter to

Job Types: Full-time, Permanent

Pay: ₹25, ₹40,000.00 per month

Experience:

  • regulatory: 2 years (Preferred)

Work Location: In person

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