Executive / Senior Executive, Regulatory Affairs (API)

Job Description

• Experience of DMF / ANDA Drug Substance module preparation, DMF review & deficiency responses.
• Good communication & coordination skills.
• Knowledge of FDA & ICH guidelines.
• Experience of Canada & EU DMF will add value.
• Local candidate is preferred for stability & to avoid language barrier

Qualifications

MSc Chemistry with 2 to 6 Yrs of experience

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.

Skills Required

Knowledge of FDA ICH guidelines, DMF ANDA Drug Substance module preparation, Experience of Canada EU DMF, DMF review deficiency responses