Hetero, one of India’s leading pharmaceutical companies and a Great Place to Work® Certified organization, has announced an exciting career opportunity for experienced Regulatory Affairs professionals. The company is seeking qualified candidates for the position of Regulatory Affairs Specialist to support formulation registrations and lifecycle management activities across international markets including ROW, EU, and US.

This opportunity is ideal for professionals with strong expertise in dossier preparation, marketing authorization applications, CMC documentation, and regulatory submissions.

Job Overview

Particulars Details

Company Name

Hetero

Position

Regulatory Affairs Specialist

Department

Regulatory Affairs

Location

Jeedimetla, Hyderabad

Experience Required

3 to 9 Years

Qualification

M.Pharm / B.Pharm / M.Sc

Markets

ROW, EU, US Formulation Markets

Employment Type

Full-Time

Key Responsibilities

Selected candidates will be responsible for:

Preparation, review, and submission of regulatory dossiers.

Managing regulatory filings for international markets.

Handling product life cycle management activities.

Managing post-approval and pre-approval regulatory submissions.

Preparing and reviewing Marketing Authorization Applications (MAA).

Supporting Chemistry, Manufacturing, and Controls (CMC) documentation.

Ensuring compliance with global regulatory requirements.

Coordinating with cross-functional teams for successful submissions.

Required Skills

Candidates should possess:

Strong knowledge of regulatory guidelines for ROW, EU, and US markets.

Experience in dossier compilation and submission.

Expertise in Life Cycle Management (LCM).

Understanding of post-approval variations and regulatory compliance.

Knowledge of MAA (Marketing Authorization Application).

Hands-on experience with CMC documentation and submissions.

Excellent documentation and communication skills.

Educational Qualification

Applicants must possess any of the following qualifications:

Master of Pharmacy (M.Pharm)

Bachelor of Pharmacy (B.Pharm)

Master of Science (M.Sc)

Work Location

Jeedimetla, Hyderabad, Telangana

Candidates willing to work from the Hyderabad location and contribute to global regulatory operations are encouraged to apply.

How to Apply?

Interested candidates can send their updated CV to:

📧 chandrasekhar.r@hetero.com

Subject Line: Application for RA

Applicants are advised to mention their current experience, qualification, current CTC, expected CTC, and notice period in the email.

Why Join Hetero?

Hetero is recognized for its commitment to:

Integrity

Innovation

Collaboration

Excellence

The organization continues its mission of making healthcare accessible to people worldwide while offering employees excellent career growth opportunities in the pharmaceutical sector.

Technical FAQs

1. What is a regulatory dossier in the pharmaceutical industry?

A regulatory dossier is a comprehensive set of documents containing information related to quality, safety, efficacy, manufacturing processes, and product specifications submitted to regulatory authorities for product approval.

2. What is Life Cycle Management (LCM) in Regulatory Affairs?

Life Cycle Management involves managing all regulatory activities after a product is approved, including variations, renewals, labeling updates, site transfers, and compliance maintenance throughout the product’s market life.

3. What is a Marketing Authorization Application (MAA)?

An MAA is a regulatory submission made to health authorities, particularly in Europe, seeking approval to market a pharmaceutical product. It contains complete quality, non-clinical, and clinical data.

4. What does CMC mean in pharmaceutical regulatory submissions?

CMC stands for Chemistry, Manufacturing, and Controls. It includes information about raw materials, manufacturing processes, product specifications, stability studies, and quality control procedures required for regulatory approval.

5. What are post-approval and pre-approval submissions?

Pre-approval submissions are regulatory documents filed before a product receives marketing authorization, while post-approval submissions involve changes after approval, such as manufacturing updates, formulation changes, labeling revisions, and regulatory variations.