location_onAhmedabad, Gujarat, India
watch_later Posted: May 02, 2025
Job Description
Key Responsibilities
JOB DESCRIPTION
Responsibilities Include, But Are Not Limited To
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.
JOB DESCRIPTION
Responsibilities Include, But Are Not Limited To
- Prepare, Review and Finalize Regulatory strategies for Complex Products [injectables that includes Peptides, Microspheres, Liposomes, Nano-suspensions, Colloids etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for Regulated markets (US, CA and EU market).
- Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA/Scientific meeting packages and follow up communications with health authorities.
- Draft and finalize controlled correspondences on complex issues.
- Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products.
- Review API and FP in-vitro characterization/sameness reports.
- DMF review for complex APIs as per the workflow.
- To collaborate and work closely with cross functional teams.
- To meet the management expectations w.r.t timelines and quality.
- To work closely within the team and provide training to new members on new regulatory requirements for Complex products.
- Suitably qualified individuals with strong Scientific and Regulatory background.
- Academic degree in Pharmacy (M. Pharm or PhD), with preferably specialization in Regulatory Affairs or Pharmaceutics.
- Experienced (minimum 10 years) in Regulatory Affairs and overall experience 12+ years.
- End to end complete understanding of Complex Products for US/ EU market right from Strategy, Filing, Deficiency response etc.
- Experienced in drafting controlled correspondences, Meeting packages etc.
- Experience being an active contributor to cross-functional teams and/or working in matrix organizations. High quality, critical thinking, process, and performance orientated; prioritizes activities and projects.
- Exercises good judgment on regulatory, quality, and technical related compliance issues. High personal integrity; trustworthy; strong compliance and quality mind-set.
- Solution orientated, strong sense of ownership and accountability.
- Collaborative, team-oriented approach, capable of working cross-functionally, and in a matrixed and integrated way.
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.
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