Officer - Regulatory Affairs

As a Regulatory Affairs Specialist, you will be responsible for leading regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market. Your role will involve ensuring timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA. Additionally, you will manage post-approval submissions and annual reports for USFDA-approved products to ensure continuous regulatory compliance and lifecycle management. Key Responsibilities: - Drive labeling updates in alignment with changes to Reference Listed Drug (RLD) labeling approved by the USFDA. - Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports) to contribute to global pharmacovigilance and safety monitoring. - Review and offer strategic input on documentation throughout product development, scale-up, and commercial manufacturing stages. - Oversee document reviews for externally manufactured products to ensure regulatory consistency and quality standards. Qualifications Required: - 1 to 2 years of experience in Regulatory Affairs for Regulated Markets. - Graduation in Pharmacy. - Masters in Science. In this role, you will be expected to demonstrate competencies such as Customer Centricity, Developing Talent, Collaboration, Strategic Agility, Process Excellence, Stakeholder Management, Innovation & Creativity, and Result Orientation. Please note that the company's additional details were not provided in the job description. As a Regulatory Affairs Specialist, you will be responsible for leading regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market. Your role will involve ensuring timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA. Additionally, you will manage post-approval submissions and annual reports for USFDA-approved products to ensure continuous regulatory compliance and lifecycle management. Key Responsibilities: - Drive labeling updates in alignment with changes to Reference Listed Drug (RLD) labeling approved by the USFDA. - Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports) to contribute to global pharmacovigilance and safety monitoring. - Review and offer strategic input on documentation throughout product development, scale-up, and commercial manufacturing stages. - Oversee document reviews for externally manufactured products to ensure regulatory consistency and quality standards. Qualifications Required: - 1 to 2 years of experience in Regulatory Affairs for Regulated Markets. - Graduation in Pharmacy. - Masters in Science. In this role, you will be expected to demonstrate competencies such as Customer Centricity, Developing Talent, Collaboration, Strategic Agility, Process Excellence, Stakeholder Management, Innovation & Creativity, and Result Orientation. Please note that the company's additional details were not provided in the job description.