Posted 09 June, 2026
Sr, Manager- Regulatory Affairs SAAUNZ
NR Consulting - India
Mumbai, Maharashtra, IN
Full Time
Reference: 26-06155-2220-1
Title: Sr, Manager- Regulatory Affairs SAAUNZ
Location: Mumbai
Exp: 11-14yrs
Job Description:
Job Responsibilities
Review & approval of technical document viz, MFC, BMR, BMR, Protocols for Hold time study, stability, process validation, PDR etc.
Interaction with Applicant /MA holders and Regulatory agencies for the current status of the project.
Manage the compilation, review and submission of new product registrations, post approval submission and follow up closely on queries and through approval.
Manage and coordinate product life cycle management.
Provide regulatory support including timely registration of new product and line extensions.
Variation filling for Australia, New Zealand and South Africa.
Coordination and follow up with supporting teams (R & D/ADL/PPIC/Client/Legal).
Responsible for Change control management.
Development of regulatory strategies, preparation of regulatory applications and support maintenance activities in relevant therapy areas.
Maintain regulatory work process and tracking tools that improve performance levels.
Overall Project management, Client management.
Support for commercial launch of the products.
Revie of Technical agreement for the applicant
Provide regulatory support including timely registration of new product for Third party products
Location: Mumbai
Exp: 11-14yrs
Job Description:
Job Responsibilities
Review & approval of technical document viz, MFC, BMR, BMR, Protocols for Hold time study, stability, process validation, PDR etc.
Interaction with Applicant /MA holders and Regulatory agencies for the current status of the project.
Manage the compilation, review and submission of new product registrations, post approval submission and follow up closely on queries and through approval.
Manage and coordinate product life cycle management.
Provide regulatory support including timely registration of new product and line extensions.
Variation filling for Australia, New Zealand and South Africa.
Coordination and follow up with supporting teams (R & D/ADL/PPIC/Client/Legal).
Responsible for Change control management.
Development of regulatory strategies, preparation of regulatory applications and support maintenance activities in relevant therapy areas.
Maintain regulatory work process and tracking tools that improve performance levels.
Overall Project management, Client management.
Support for commercial launch of the products.
Revie of Technical agreement for the applicant
Provide regulatory support including timely registration of new product for Third party products
