Deputy Manager, Regulatory Affairs | NCE | CDSCO and Global Regulatory Agen at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

29 Apr, 26

Salary

0.0

Posted On

29 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, NCE Projects, eCTD Format, Regulatory Submissions, ICH Guidelines, USFDA Compliance, EMA Compliance, CDSCO Guidelines, Pharmacovigilance, Audit Preparation, Regulatory Intelligence, Clinical Trial Applications, Documentation Management, Collaboration, Process Improvements

Industry

Pharmaceutical Manufacturing

Description

Job Description: To support the development and execution of regulatory strategies for NCE projects, including 505(b)(2) pathways. To prepare, compile, and review IND, NDA, ANDA, and MAA dossiers in eCTD format. To coordinate timely submission of regulatory documents to CDSCO and global health authorities. To ensure all submissions comply with ICH, USFDA, EMA, CDSCO, and other applicable guidelines. To assist in preparing responses to regulatory queries, deficiency letters, and follow‑up requirements. To coordinate communication with CDSCO, global agencies, and partner affiliates under supervision. To support the arrangement and documentation of regulatory meetings and discussions with authorities. To track updates in regulatory requirements and communicate relevant changes to stakeholders. To ensure adherence to GxP, pharmacovigilance norms, and internal compliance processes. To assist in audit preparation and support during regulatory inspections. To collaborate with R&D, Clinical, CMC, Quality, and Commercial teams for regulatory inputs. To support documentation and submissions related to clinical trial applications and product development. To conduct regulatory intelligence and compile summaries on global guideline changes and competitor activity. To maintain regulatory documentation, submission trackers, and archives for assigned projects. To support senior regulatory team members and contribute to standardization and process improvements. 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. 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

The Deputy Manager will support the development and execution of regulatory strategies for NCE projects and ensure compliance with various regulatory guidelines. Responsibilities include preparing regulatory submissions, coordinating communications with health authorities, and tracking updates in regulatory requirements.