Regulatory Affairs Specialist

Hetero Labs Limited Unit VII, Hyderabad

Role Description

This is a full-time, on-site role. The Regulatory Affairs Specialist will prepare, review, and maintain regulatory documentation for various markets, ensuring accuracy, consistency, and alignment with current guidelines. The role involves coordinating regulatory submissions, tracking their status, and responding to queries from regulatory authorities. The specialist will interpret and apply regulatory requirements, support cross-functional teams in compliance-related matters, and assist in change control and impact assessments. Daily activities also include keeping up-to-date with evolving regulatory frameworks, supporting audits and inspections, and contributing to continuous improvement of regulatory processes and systems.

Key Responsibilities

• Prepare, review, and maintain regulatory documentation.
• Coordinate regulatory submissions.
• Track the status of regulatory submissions.
• Respond to queries from regulatory authorities.
• Interpret and apply regulatory requirements.
• Support cross-functional teams in compliance-related matters.
• Assist in change control and impact assessments.
• Keep up-to-date with evolving regulatory frameworks.
• Support audits and inspections.
• Contribute to continuous improvement of regulatory processes and systems.

Qualifications

• Strong skills in Regulatory Documentation and Regulatory Submissions to prepare, compile, and track dossiers and filings.
• Expertise in Regulatory Compliance and Regulatory Requirements to ensure products and processes meet local and international standards.
• Solid foundation in Regulatory Affairs to liaise with authorities and support internal stakeholders on regulatory strategies.
• Excellent attention to detail, organizational skills, and the ability to manage multiple projects and deadlines.
• Strong communication and collaboration skills to work effectively with QA, QC, R&D, production, and other functions.
• Proficiency in MS Office and regulatory tracking tools.
• Experience with international regulatory frameworks (e.g., US, EU, WHO) is an advantage.
• A degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Prior experience in pharmaceutical regulatory affairs is highly preferred.