Executive - RA (US ANDA)

Job Description

🔹 Lead regulatory submissions for Oral Solid Dosage (OSD) for the US market.
🔹 Ensure timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA.
🔹 Manage post-approval submissions and annual reports for USFDA-approved products, ensuring continuous regulatory compliance and lifecycle management.
🔹 Drive labeling updates in line with changes to Reference Listed Drug (RLD) labeling approved by the USFDA.
🔹 Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports), contributing to global pharmacovigilance and safety monitoring.
🔹 Review and offer strategic input on documentation across product development, scale-up, and commercial manufacturing stages.
🔹 Oversee document reviews for externally manufactured products, ensuring regulatory consistency and quality standards.

Work Experience

2 to 3 years experience in regulatory submissions for Oral Solid Dosage (OSD) for the US market.

Education

Competencies