Hetero Hiring for Regulatory Affairs – API Role

Hetero, a global pharmaceutical leader, is hiring for the Regulatory Affairs – API department at its Hyderabad location. This opportunity is ideal for candidates holding a Master’s or Bachelor’s degree in Organic Chemistry or Pharmaceuticals (MSc, M.Pharm, B Pharm) with 2–8 years of experience in regulatory affairs, specifically in the Active Pharmaceutical Ingredients (API) segment.

This is your chance to be part of an innovative, fast-paced team that plays a vital role in Hetero’s global regulatory success.

Job Overview: Regulatory Affairs – API Role

Location: Hyderabad

Department: Regulatory Affairs – API

Experience Required: 2–8 years

Qualifications:

MSc (Organic Chemistry), M.Pharm (Pharmaceuticals), B Pharm (Pharmaceuticals)

Key Responsibilities: 

As part of the Regulatory Affairs – API team, your responsibilities will include:

• Compilation and submission of DMFs and CEPs for global markets such as the US, EU, China, Brazil, and LATAM.
• Preparing regulatory dossiers in accordance with international (ICH) guidelines and regional requirements.
• Handling annual reports, regulatory amendments, and variation filings.
• Participating in deficiency response meetings, coordinating with R&D, QA, and other internal teams.
• Reviewing documents for compliance, identifying gaps, and ensuring alignment with updated regulatory standards.
• Keeping up with changing global regulatory frameworks and implementing updates to documentation and processes.

Ideal Candidate Profile

To succeed in this role, you should bring:

• Proven experience in DMF and CEP compilation, submission, and lifecycle management.
• Sound knowledge of USFDA, EMA, and ICH guidelines.
• Excellent attention to detail, document management, and communication skills.
• Ability to manage multiple regulatory submissions simultaneously.
• A collaborative mindset and readiness to work in cross-functional teams.

Perks and Benefits: 

• Opportunity to work with a globally recognized pharma leader.
• Exposure to emerging and regulated markets.
• Continuous learning and development opportunities.
• Competitive compensation and a dynamic work environment.

How to Apply

If you’re passionate about regulatory affairs and want to grow in a globally res

pected organization, email your updated resume to:

prathap.p@hetero.com