Hetero hiring Regulatory Affairs

M.Pharm RA Specialist Vacancy Hyderabad

M.Pharm/B.Pharm/M.Sc Regulatory Affairs Specialist vacancy in Hyderabad. 3–9 yrs experience in ANDA, CMC & MAA submissions.

Hetero is hiring experienced Regulatory Affairs professionals for its Formulation division at Jeedimetla, Hyderabad. If you have solid exposure to ANDA submissions, lifecycle management, CMC documentation, and global regulatory filings for Emerging Markets or ROW (Rest of World), this is a strong career opportunity in one of India’s leading pharmaceutical companies.

This role is ideal for professionals looking to grow in pharmaceutical regulatory affairs, global dossier submission, and compliance-driven formulation development.

Company Overview

Hetero is a globally recognized pharmaceutical company with a strong footprint in APIs, generics, biosimilars, and formulations. The organization serves regulated and semi-regulated markets across the US, Europe, and ROW territories.

With a focus on affordable healthcare and large-scale manufacturing excellence, Hetero operates USFDA-approved facilities and maintains strict compliance with international regulatory authorities. The company’s Regulatory Affairs division plays a critical role in global product registration, lifecycle management, and compliance strategy.

Joining Hetero means working in a structured regulatory environment aligned with USFDA, EMA, and other global health authority guidelines.

Job Role & Responsibilities – Regulatory Affairs Specialist (Formulation)

The selected candidate will be responsible for handling regulatory submissions and post-approval activities for formulation products across Emerging Markets and ROW regions.

Core Responsibilities

• Review, compilation, and submission of ANDA dossiers
• Preparation and filing of Marketing Authorization Applications (MAA)
• Handling pre-approval and post-approval regulatory activities
• Managing lifecycle management (LCM) activities for registered products
• Preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation
• Handling regulatory variations and amendments
• Coordination with cross-functional teams including R&D, QA, and Manufacturing
• Ensuring compliance with country-specific regulatory requirements

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This role directly contributes to global product approvals and commercial success in regulated and emerging pharmaceutical markets.

Eligibility / Qualifications

Educational Qualification

M.Pharm, B.Pharm, M.Sc

Relevant Academic Background:
Pharmaceutics, Pharmaceutical Chemistry, Regulatory Affairs, Quality Assurance, Industrial Pharmacy, Analytical Chemistry

Experience Required

3 to 9 years of experience in Regulatory Affairs (Formulation sector preferred)

Required Skill Set

• Strong knowledge of ANDA compilation and submission process
• Experience in MAA filing for Emerging Markets/ROW
• Hands-on exposure to CMC documentation
• Experience in handling regulatory variations
• Understanding of global regulatory guidelines
• Strong documentation and review skills

Candidates with prior experience in USFDA-regulated or EU-compliant facilities will be preferred.

Location & Work Environment

Job Location: Jeedimetla, Hyderabad

The Jeedimetla facility is part of Hetero’s regulated market operations and supports global dossier submission and lifecycle management functions. Professionals working here gain exposure to international regulatory standards and structured compliance systems.

Salary: As per company norms. Competitive package aligned with industry standards for Regulatory Affairs Specialists.

Application Process

Interested candidates can share their updated CV to:

Email: chandrasekhar.r@hetero.com
Subject Line: Application for RA

Only shortlisted candidates will be contacted for further rounds.

Why Regulatory Affairs is a High-Value Pharma Career

Regulatory Affairs professionals play a strategic role in global pharmaceutical commercialization. From ANDA approvals to lifecycle management and variation handling, RA specialists ensure that products meet international compliance standards and reach patients without regulatory delays.

This position offers:

• Exposure to global dossier submission (ANDA/MAA)
• Experience in lifecycle management strategies
• Cross-functional collaboration with R&D and manufacturing
• Strong long-term career growth in regulatory compliance
• Opportunities in high-demand global pharma markets

Frequently Asked Questions (FAQs)

1. What experience is required for this RA role?

Candidates must have 3–9 years of experience in Regulatory Affairs, preferably in formulation.

2. Is ANDA experience mandatory?

Yes, exposure to ANDA review and submission is essential.

3. What markets will this role handle?

Emerging Markets and ROW (Rest of World) territories.

4. What qualifications are accepted?

M.Pharm, B.Pharm, and M.Sc graduates are eligible.

5. Is lifecycle management experience required?

Yes. Experience in post-approval changes and lifecycle management is expected.

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Summary Table

Company	Hetero
Vacancies	Regulatory Affairs Specialist (Formulation – Emerging Markets/ROW)
Required Education	M.Pharm, B.Pharm, M.Sc
Experience	3–9 Years