Assistant Manager, Regulatory Affairs (DMF Peptide Exposure)

• Prepare and review Peptide API Drug Master Files (DMFs) for submission to the US FDA and other regulatory agencies.
• Handle deficiency responses and interact with regulatory authorities for query resolution and clarification.
• Prepare and manage ANDA Drug Substance Modules and support associated submissions and updates.
• Compile and submit DMFs, and support any lifecycle management or post-submission queries.
• Maintain current knowledge of regulatory guidelines and ensure regulatory compliance across all submissions.
• Participate in internal and external project discussions and contribute to the preparation of regulatory project presentation slides and documentation.
• Ensure coordination between R&D, Quality, and Manufacturing teams for gathering and verifying technical data.
• Exhibit strong technical writing and communication skills to ensure clarity and compliance in submissions.
• Support regulatory strategy development and planning for new drug substance filings.
  

Required Skills

• Peptide API DMF Preparation | Expert
• DMF Review & Deficiency Responses | Expert
• Regulatory Knowledge | Expert
• Technical Writing | Expert
• Communication & Coordination | Expert
  

Qualifications

Masters in Chemistry or Organic Chemistry or M. Pharm

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The

Human Resources team

partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.