Deputy Manager, Regulatory Affairs Injectable US Market

Job Description

Strong Regulatory CMC background focused on complex Injectable / Ophthalmic-Otic Dosage form

Qualifications

• Hands-on knowledge of Parenteral dosage form
• Having Experience in the US, Europe, and Canada Dossier submission
• Compilation & Review of quality ANDAs / MAA / ANDS / 505(b)2 for General and Complex Injectable / Ophthalmic-Otic Products within the timeline.
• Preparation and Review of Meeting Packages for ANDA / NDA
• Compilation and review of Amendments / Query responses within the stipulated timeline for Injectable products.
• Review of technical documents received from PD, ARD, QA, QC, Production, and CRO to include as part of the Dossier.
• Follow up with the cross-functional team for completion of the assigned technical and regulatory task.
• Preparation and Review of regulatory strategy / white papers for General and Complex Injectable / Ophthalmic-Otic Products.
• Primary review of DMFs of General and Complex Injectable API and follow up with the purchase team for vendor documentation.
• Preparation and review of Controlled Correspondences for General and Complex Injectable products.
• Co-ordination with R&D, ARD, QC, QA, Clinical, Labeling team for any outstanding technical task and escalation with superiors for resolution.
• Monitoring the changes in regulations, regulatory procedures & guidance, and evaluating the impact on the product life cycle.

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.

Skills Required

Primary review of DMFs, Dossier submission, Preparation and review of regulatory strategy white papers, Parenteral dosage form, ANDS 505 b 2, Preparation and review of Controlled Correspondences, Preparation and review of Meeting Packages for ANDA NDA, Compilation and review of Amendments, Review of technical documents, MAA