Assistant Manager - Regulatory Affairs

Impronics Technologies; Mumbai; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Impronics Technologies is seeking an expert in regulatory activities including CTD dossier preparation and query management. The role involves compiling dossiers in eCTD format and coordinating with various regulatory authorities globally.

The ideal candidate should have strong communication skills, be adept in managing product lifecycle variations, and maintain trackers of queries. This position is critical to ensure compliance with international regulatory standards.

Responsibilities

• Conduct gap analysis of dossiers for completion.
• Compile and submit eCTD dossiers to regulatory authorities.
• Coordinate query responses and ensure deadlines are met.
• Manage variations and renewals of product lifecycle.
• Communicate with internal and external stakeholders.
• Update trackers for queries and variations regularly.

Job description

Technical competencies/ Professional expertise

Expert in regulatory activities like CTD dossier preparation, query solving, well worse with ICH guidelines and updated with current regulatory guidelines.

Key Performance area

New Dossier Preparation and submission

• Gap analysis of dossier for completion
• Compilation of dossier in eCTD for submission to various regulatory authorities
• Coordinate submission of dossiers in various countries

Query Evaluation and Submission

• Receipt of the query letters from the respective country team
• Co‑ordination with the manufacturer for the query response
• Review of the query response received from the manufacturer.
• Final compilation of query response and roll out to the respective countries
• Ensuring the deadlines.

Post approval - lifecycle management of product (Variation)

• Receipt of the variation / renewal package from FPP manufacturer / or initiation of variation from Innovata’s end.
• Review of the variation package as per the variation guidelines of the respective country guidelines
• Co‑ordination with the manufacturer.
• Final compilation of the variation package and roll out to respective countries
• Strictly monitoring harmonisation of dossier/queries/variation across all countries.

Artworks

Development of artworks and approval as SOP for queries and variations as applicable.

Daily Communication

• Communication with internal (BD, marketing, logistics, legal, designing, country RA teams etc depts.) and external stakeholders (manufacturing suppliers, country agents, vendors, consultants etc.).

Updating of the trackers

• Updating of the trackers of queries and variations on regular basis.
• Attending unit and regional meetings, trainings, meetings with the manufacturers, telecons (internal and external stakeholders).
• Attending trainings identified by line manager & organised by Intellectus Campus.