Senior Executive, Regulatory Affairs, Pre Approval Injectable USA Market

Key Responsibilities

Your Responsibilities Include, But Are Not Limited To

• Prepare Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.
• Draft Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
• Draft controlled correspondences on complex issues.
• Draft 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.
  

Qualifications

MINIMUM REQUIREMENTS:

• Suitably qualified individuals with strong Scientific and Regulatory background.
• Academic degree in Pharmacy (M. Pharm), with preferably specialization in Regulatory Affairs or Pharmaceutics.
• Experienced (minimum 3 years) in Regulatory Affairs and having hands-on experience in Injectable dosage form that includes (but not limited to) submission of ANDA, responding to deficiencies, FDA communications etc.
• 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.
  

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.