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

Graduation in Pharmacy

Competencies

Strategic Agility

Process Excellence

Collaboration

Innovation & Creativity

Result Orientation

Stakeholder Management

Customer Centricity

Developing Talent