Regulatory Affairs Executive
Location: Hyderabad, Telangana, India
Company: Hetero
Employment Type: Full-time, On-site
Level: Executive
About Hetero:
Hetero is a leading global pharmaceutical company dedicated to manufacturing high-quality generic medicines. With a workforce of over 10,000 employees, Hetero is committed to making affordable healthcare accessible worldwide. Our team in Hyderabad, Telangana is expanding, and we are seeking a talented Regulatory Affairs Executive to join our dynamic regulatory affairs team.
About the Role:
As a Regulatory Affairs Executive at Hetero, you will play a crucial role in ensuring the compliance and approval of our pharmaceutical products, specifically focusing on the US market. You will work closely with various teams to prepare, review, and submit regulatory documentation, ensuring that our products meet all necessary standards and regulations.
Key Responsibilities:
- Manufacture and Testing Knowledge: Demonstrate expertise in the manufacture and testing of sterile products, including understanding environmental conditions during sterile product manufacturing.
- Document Review: Review and clear pre-exhibit batch R&D documents such as formula clearance concerning Q1/Q2, IIG, specifications/STP of raw materials, packaging, in-process, and finished products in line with ICH and USP guidelines.
- ANDA Compilation and Submission: Compile, review, and submit Abbreviated New Drug Applications (ANDAs) for generic and new drug applications to the US FDA.
- Deficiency Responses: Follow up with cross-functional teams (CFTs) to complete action items related to deficiency comments and prepare clear and thorough responses to each comment.
- Lifecycle Management: Manage the lifecycle of approved drug products, including CBE-30 (Changes Being Effected in 30 days), PAS (Prior Approval Supplement), and annual reports.
- Validation Summaries: Compile and/or review sterility assurance validation summaries required for original and post-approval submissions.
Qualifications and Skills:
- Education: Bachelor’s degree in a relevant scientific discipline.
- Experience: Proven experience in regulatory affairs within the pharmaceutical industry, particularly with US FDA submissions.
- Technical Skills: Proficiency in the preparation and submission of ANDAs, understanding of sterile product manufacturing, and knowledge of regulatory guidelines (ICH, USP).
- Skills:
- Abbreviated New Drug Application (ANDA)
- Regulatory Affairs
- Knowledge of environmental conditions in sterile product manufacturing
- Strong analytical and problem-solving skills
- Excellent communication and organizational skills
- Ability to manage multiple projects and deadlines