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Deputy General Manager, Regulatory Affairs | NCE at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

14 Jun, 26

Salary

0.0

Posted On

16 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, NCEs, 505(b)(2) Submissions, Regulatory Filings, CDSCO Compliance, International Agencies, Product Lifecycle Management, Regulatory Affairs

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

This role is responsible for leading the regulatory strategy for New Chemical Entities (NCEs), which includes managing 505(b)(2) submissions for both India and global markets. The Deputy General Manager will oversee regulatory filings, ensure adherence to CDSCO and international agency requirements, and provide strategic direction throughout the product lifecycle.