The Sr. Executive will ensure regulatory compliance across all stages of the product lifecycle and handle ANDA, NDA, and post-approval activities. This includes preparation, submission, review, and regulatory correspondence with agencies such as the US FDA, Health Canada, and EMA.
Key Responsibilities
- Labeling and Documentation:
- Review product labels and Summary of Product Characteristics (SPL) for submissions.
- Regulatory Submissions:
- Prepare, compile, and submit pre- and post-approval documents for US, EU, and ROW markets.
- Handle eCTD dossiers for USFDA ANDA/EU-MAA applications.
- Data Gathering and Validation:
- Collaborate with stakeholders to gather required specifications, batch records, and validation data for submissions.
- Review method validation and analytical documents for regulatory compliance.
- Regulatory Correspondence:
- Manage responses to deficiencies from regulatory authorities and ensure timely resolutions.
- Compliance Reporting:
- Prepare and submit Annual Reports, PADERs (Periodic Adverse Drug Experience Reports), and other relevant reports.
Qualifications and Experience
- Education:
- B.Pharm / M.Pharm (Mandatory)
- Experience:
- 6+ years of experience in USFDA, ANDA, and European regulatory submissions.
- Hands-on experience managing ANDA/NDA submissions.
What We Offer
- Collaborative work environment with exposure to regulated markets.
- Opportunities to work with cross-functional teams across India and the US.
- Training and development opportunities in a growing pharmaceutical company.
