Assistant Manager, Regulatory Affairs

The role involves preparing and reviewing Peptide API Drug Master Files (DMFs) for submission to regulatory agencies, including the US FDA. You will be responsible for handling deficiency responses and engaging with regulatory authorities to resolve queries. Additionally, you will manage ANDA Drug Substance Modules and support associated submissions and updates. Your duties will also include compiling and submitting DMFs, as well as providing support for lifecycle management and post-submission queries. It is crucial to stay abreast of regulatory guidelines to ensure compliance across all submissions. You will participate in internal and external project discussions, contributing to the preparation of regulatory project presentation slides and documentation. Effective coordination between R&D, Quality, and Manufacturing teams is essential for gathering and verifying technical data. Strong technical writing and communication skills are paramount to ensure clarity and compliance in submissions. Furthermore, you will be involved in supporting regulatory strategy development and planning for new drug substance filings. Required Skills: - Proficiency in Peptide API DMF Preparation - Expertise in DMF Review & Deficiency Responses - Strong knowledge of Regulatory Requirements - Advanced Technical Writing abilities - Excellent Communication and Coordination skills Qualifications: - Master's degree in Chemistry, Organic Chemistry, or M. Pharm Amneal is an equal opportunity employer that values diversity and inclusion, refraining from discrimination based on caste, religion, gender, disability, or any other legally protected status. The Human Resources team at Amneal collaborates with all sectors of the organization, ensuring effective people management to drive success for present and future business needs. The team fulfills various key roles, including: - Executive Role: Providing specialized input on people management at a strategic level in key business decisions. - Audit Role: Ensuring compliance with legal requirements and best practices in employment policies and procedures. - Facilitator Role: Supporting all areas of the organization through effective employment practices in Talent Acquisition, Learning and Development, Reward systems, Performance Management, and Health and Wellbeing. - Consultancy Role: Offering expert advice on workforce management, employee relations, and performance to the organization and its managers. - Service Role: Ensuring awareness and preparedness within the organization for developments impacting employment matters, such as legislative changes and shifts in the labor market characteristics.,