We are seeking a knowledgeable and detail-oriented Drug Regulatory Affairs professional to join our team in India. The ideal candidate will be responsible for ensuring compliance with regulatory requirements for pharmaceutical products, managing submissions, and facilitating communication with regulatory bodies.
- Strong understanding of FDA, ICH, CMC, and labeling requirements
- Prepare and submit regulatory documents, lead labeling development, and ensure compliance with FDA regulations
Role & responsibilities
- Prepares the submissions (ANDAs, amendments, supplements including labeling, annual reports) to support commercial business and to be-in compliance to FDA regulations.
Responsibilities
- Prepare and submit regulatory documents to government authorities in compliance with regulations.
- Review and assess product labeling and promotional materials for compliance with applicable laws.
- Maintain knowledge of changes in regulations and guidelines that may affect product approvals and compliance.
- Coordinate with cross-functional teams including R&D;, Quality Assurance, and Marketing to ensure regulatory requirements are met.
- Assist in the preparation of responses to regulatory agency inquiries and inspections.
Skills and Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, or a related field.
- 2-4 years of experience in drug regulatory affairs, preferably in the pharmaceutical industry.
- Robust knowledge of Indian regulatory framework and guidelines related to drugs and pharmaceuticals.
- Excellent written and verbal communication skills to effectively convey complex regulatory concepts.
- Ability to work collaboratively in a team environment and manage multiple projects simultaneously.