This job profile involves preparing regulatory dossiers and submissions for markets in Asia, Europe, and other regions. Key responsibilities include compiling technical documentation and administrative information for dossiers, ensuring compliance with various regulatory guidelines, and responding to queries from authorities. The ideal candidate will have excellent communication and leadership skills to facilitate cross-functional collaboration on registration strategies and deliver high-quality submissions on schedule.

1. JOB PROFILE:
 Responsible for the dossier preparation as per ACTD, CTD and country specific for
ROW market and Europe market.
 Preparation of dossiers CMC modules in CTD formats to regulatory authorities.
 Preparation and submission of dossiers ANDA’s CTD formats to regulatory
authorities.
 Compilation & Preparation of ACTD for Asian countries like Cambodia, Vietnam
and Singapore.
 Preparation, compilation &registration of documents that include Administrative &
Technical.
 Responsible for the review of dossier as required for country guidelines.
 Responsible for planning, preparation and review of variations (Minor and Major) as
required based on country specific as per WHO guidelines.
 Responsible for planning, preparation and review of renewal dossier as per validity
period.
 Responsible for responding the queries in time.
 Reviewed documents including labeling drafts, BMR’s, BPR’s, PDR’s (QbD format)
Raw Material/Finished Product Specifications & STP’s, CoA’s, APR’s, stability
protocols & specifications, Stability Analytical data and process validation reports as
well as validation of analytical method for regulatory compliance.
 Review of the documents such as art works, finished product, stability protocol and
reports, specifications, test methods, process validation protocol and report,
Pharmaceutical development report which are part of regulatory submission.
DESIRED SKILLS
 Having liability to high quality registration-related documentation and presentations
which meets timelines
 Make and meet customer expectations on regulatory sustainable and deliverables.
 Having excellent communication and conciliation skills and strong leadership skills,
signifying the values and behaviors.
 Respected Regulatory leader within department and/or other line functions.
 Having flexibility to build valuable working interaction and deliver results in wide
range of environments and cultures.

2.  Sustain strong relationships with various departments like R&D, IPR, QA & QC,
Production, Audit compliance, Corporate & IBD teams to facilitate the development
and implementation of registration strategies to expedite the registration of products
and life-cycle optimization.