Manager, Regulatory Affairs

Role Overview: You will be responsible for extensive knowledge of ANDA & ANDS submission activities and post-approval procedures following ICH, USFDA, and Health Canada guidelines. Additionally, you will review API DMF in alignment with complete USFDA regulatory requirements and possess thorough knowledge of various dosage forms and key manufacturing processes. Your role will involve finalizing Annual Reports with required submission data as per USFDA guidance and ensuring timely submissions, as well as conducting high-quality reviews of submission packages to avoid deficiencies. Key Responsibilities: - Assess dynamic change cases in ICH Quality/post-approval USFDA guidance and understand Post-approval submission guidelines for Annual report/CBE 0/CBE 30 and PAS filling - Manage major supplements submissions and approval process efficiently - Coordinate with Cross-Functional teams for document acceptance as per regulatory requirements - Maintain regulatory information in accordance with current department practices - Demonstrate good Regulatory review and communication skills - Exhibit strong team management skills Qualifications: - B. Pharm / M. Pharm Additional Company Details: Amneal is an equal opportunity employer that values diversity and inclusion, ensuring a workplace free from discrimination based on caste, religion, gender, disability, or any other legally protected status. The Human Resources team at Amneal partners with the organization to drive success through effective people management, ensuring compliance with legal requirements and best practices while supporting all areas of the organization in meeting their objectives through highly effective employment practices. Role Overview: You will be responsible for extensive knowledge of ANDA & ANDS submission activities and post-approval procedures following ICH, USFDA, and Health Canada guidelines. Additionally, you will review API DMF in alignment with complete USFDA regulatory requirements and possess thorough knowledge of various dosage forms and key manufacturing processes. Your role will involve finalizing Annual Reports with required submission data as per USFDA guidance and ensuring timely submissions, as well as conducting high-quality reviews of submission packages to avoid deficiencies. Key Responsibilities: - Assess dynamic change cases in ICH Quality/post-approval USFDA guidance and understand Post-approval submission guidelines for Annual report/CBE 0/CBE 30 and PAS filling - Manage major supplements submissions and approval process efficiently - Coordinate with Cross-Functional teams for document acceptance as per regulatory requirements - Maintain regulatory information in accordance with current department practices - Demonstrate good Regulatory review and communication skills - Exhibit strong team management skills Qualifications: - B. Pharm / M. Pharm Additional Company Details: Amneal is an equal opportunity employer that values diversity and inclusion, ensuring a workplace free from discrimination based on caste, religion, gender, disability, or any other legally protected status. The Human Resources team at Amneal partners with the organization to drive success through effective people management, ensuring compliance with legal requirements and best practices while supporting all areas of the organization in meeting their objectives through highly effective employment practices.