Hetero Hiring Regulatory Affairs Specialist

Regulatory Affairs Specialist Openings for M.Pharm, B.Pharm at Hetero Hyderabad

Apply for Regulatory Affairs Specialist roles at Hetero, Hyderabad. Openings for M.Pharm, B.Pharm, M.Sc with 3–9 years’ experience in pharma regulatory affairs.

Hetero, a global pharmaceutical leader, is inviting applications for the position of Regulatory Affairs Specialist at its Hyderabad (Jeedimetla) facility. This opportunity is ideal for experienced professionals with 3–9 years of expertise in regulatory affairs who want to contribute to the company’s growth across multiple markets including ROW, EU, and the US.

Company Overview

Hetero is one of India’s largest and most diversified pharmaceutical companies, with a strong presence in over 126 countries. Renowned for its world-class manufacturing facilities, extensive R&D capabilities, and commitment to affordable healthcare, Hetero has established itself as a trusted partner for both domestic and international markets.

With a product portfolio spanning APIs, generics, biosimilars, and specialty medicines, Hetero plays a vital role in addressing global healthcare challenges. The company has a proven track record of compliance with regulatory authorities including USFDA, EMA, MHRA, CDSCO, and WHO, making it a strong platform for regulatory professionals seeking long-term career stability.

Job Role & Responsibilities

As a Regulatory Affairs Specialist, you will be responsible for ensuring successful product registrations, lifecycle management, and compliance with international standards. Key responsibilities include:

  • Preparation, review, and submission of regulatory dossiers for ROW, EU, and US markets.
  • Hands-on exposure to lifecycle management of pharmaceutical products.
  • Handling both pre-approval and post-approval regulatory activities.
  • Knowledge and experience in Marketing Authorization Application (MAA) processes.
  • Expertise in CMC (Chemistry, Manufacturing, and Controls) documentation.
  • Collaborating with cross-functional teams to support regulatory submissions and audits.

Eligibility / Qualifications

  • Educational Qualification: M.Pharm, B.Pharm, or M.Sc (Pharmaceutical Sciences, Pharmaceutical Chemistry, Industrial Pharmacy, Regulatory Affairs, Quality Assurance).
  • Experience Required: 3–9 years of proven experience in Regulatory Affairs, preferably in formulations for ROW, EU, and US markets.
  • Skills & Knowledge:
    • Strong understanding of international regulatory guidelines.
    • Experience in dossier submissions (CTD/eCTD).
    • Excellent communication and documentation skills.

Location & Salary

  • Work Location: Jeedimetla, Hyderabad
  • Salary: Competitive salary package based on qualifications and experience, as per industry norms.

Application Process

Interested and eligible candidates should apply by sending their updated CV to the official recruitment email.

Apply before 23rd August 2025 to secure your chance to join Hetero’s regulatory affairs team!

FAQs

1. Who can apply for the Regulatory Affairs Specialist role at Hetero?
Candidates with M.Pharm, B.Pharm, or M.Sc qualifications and 3–9 years of regulatory affairs experience are eligible.

2. What markets will this role cover?
The role involves regulatory submissions and lifecycle management for ROW, EU, and US markets.

3. What kind of experience is preferred?
Candidates with exposure to dossier preparation, CMC documentation, and MAA applications are preferred.

4. Where is the job located?
The position is based at Hetero’s Jeedimetla facility in Hyderabad.

5. How do I apply?
Send your CV to chandrasekhar.r@hetero.com with the subject line “Application for RA.”

Summary Table

Category Details
Company Hetero
Vacancies Regulatory Affairs Specialist
Required Education M.Pharm, B.Pharm, M.Sc (Pharmaceutical Sciences, Pharmaceutical Chemistry, Regulatory Affairs, Industrial Pharmacy, Quality Assurance)
Experience 3–9 Years (Pharma industry – Regulatory Affairs)

To apply for this job email your details to chandrasekhar.r@hetero.com