Manager, Clinical Regulatory Affairs

• Develops and implements submission strategies for 505(b)(2), ANDAs and NDAs.
• Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support of all global projects for ANDAs and 505(b0(2) NDAs and EU and UK Marketing Authorizations.
• Critically reviews and approves documentation from clinical development, non-clinical development, Research and Development (R&D), Quality, Technical Operations, Labeling and other appropriate departments, internal and stakeholders, vendors and consultants.
• Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with the rationale.
• Interprets regulations and guidance documents and provides strong regulatory leadership to project teams to ensure regulatory success.
• To supports Specialty projects and International Markets.
• To develop strategies during product development, authoring submissions and providing required responses to Regulatory Agencies.
  

Required Skills

• Global Regulatory Submissions | Advance
• Regulatory Strategy Development | Expert
• Documentation Review & Approval | Advance
• Product Development Support | Advance
• International Regulatory Knowledge | Intermediate
  

Qualifications

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.