🔹 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
We are looking for a seasoned and passionate Product/Marketing Professionals with experience in managing product portfolio in Structural heart (TAVI)...
Apply For This JobDirect Taxation Proper TDS Accounting as per the applicable rules. Checking of TDS exemption limits, obtained by vendors Correct accounting...
Apply For This JobAbout Us Khao Aur Khane Do is built on a simple idea—sharing the food we grew up eating, made the...
Apply For This JobProvide patient care, manage medical records, and facilitate insurance-related tasks. Provide direct patient care and support Administer medications and treatments...
Apply For This JobDesignation: Logistics Operations Executive Location: Mumbai (Ghatkopar East) Experience: 2+ Years Salary: Upto 4.80 LPA Job Profile Job Overview: We...
Apply For This JobWe help the world run better At SAP, we keep it simple: you bring your best to us, and we’ll...
Apply For This Job