Regulatory Affairs Manager - Genpact India Pvt. Ltd. (Previously Pharmalink Consulting)
(2012-05 - 2024-07)
Initially (at Pharmalink Consulting), worked as a CMC strategist for a US pharma client. The role and responsibilities involved preparation of registration dossier strategies for initial and second brand registrations of various products for emerging markets of various countries. Product dossier strategies were prepared with the aid of source documents from legacy dossiers and current registration documents.
Further, took up another role of ancillary documents coordinator and reviewer for the same US pharma client. The role and responsibilities involved requesting, coordinating, tracking and follow up of region specific ancillary documents, and also certain CMC documents for Initial registration, Renewals, BoH queries, Variations for drug products which included conventional drug products, consumer products, investigation products, bio molecules. From Feb 2020 - Oct 2023, worked as both Quality control and Document Specialist for another US Pharma client.
- Prepared registration dossier strategies for initial and second brand registrations of various products for emerging markets
- Drafted and submitted HA query responses, rework and additional documents submissions
- Requested, coordinated, tracked and followed up region specific ancillary documents and CMC documents for Initial registration, Renewals, BoH queries, Variations for drug products
- Coordinated with API, bulk, manufacturing, and packaging sites, various stakeholders, and also with the client
- Rephrased ancillary documents as per country requirements and performed submission readiness
- Provided process related guidance to new team members for ancillary document systems and processes
- Undertook responsibility of training and final handover of project to in-house client team
- Filed variations for various MAA transfer submissions for MAH transfer, site transfer, Legal entity transfer for APAC, LATAM, EMEA regions
- Reviewed country requirements from standard templates available for each country and transfer types
- Sent kick-off emails to country representatives to seek confirmation for finalizing requirements for submissions
- Prepared draft ancillary documents such as LOA, POA, various country-specific declarations
- Raised requests for administrative documents such as GMP, ML, COC, Establishment license from site contacts and forwarded them for legalization
- Raised CPPs requests wherever applicable as per individual country requirement
- Raised requests and coordinated for CMC documents from a dedicated CMC team as per country/product and variation-specific requirements
- Raised requests to publishers through dedicated client system for dispatch and archival of the dossier
- Performed QC review of all submission packages compiled for Global MA transfers such as Legal entity name change, Site name change variations, MAH variations for EMEA, Middle East, LATAM, APAC countries
- Extended support for draft document preparation for EMEA, APAC, Middle East countries, and the US market during high volume of submissions with stringent timelines
- Involved in initial groundwork activities of the project, such as preparation of job aids, table of content of various countries, conducting knowledge transfer sessions, and reviewing product lists
- Moved to a new project (UK Pharma client) for consumer change control from Nov 2023
- Completed all process and system-related training for getting access to systems as per project requirement
- Involved in initial client meetings for discussing scope and initial groundwork assigned by client
Regulatory Affairs Executive - Macleods Pharmaceuticals Ltd.
(2009-09 - 2012-05)
- Prepared registration CTD dossiers for CIS, LATAM, APAC, African, and Middle East countries
- Drafted prompt responses to queries (RTQs) and additional documents upon request for all above countries
- Took up the responsibilities of all LCM related activities for CIS countries (Azerbaijan, Ukraine, Kazakhstan, Russia, Georgia, Uzbekistan, Moldova, Belarus)
- Prepared registration dossiers for CIS countries
- Arranged samples and standards for CIS countries
- Filled work orders for CIS countries
- Raised request and coordination with artwork and labeling department for CIS country specific artworks
- Kept track of the registration status and licenses of all product applications of CIS countries
- Prepared and maintained Normative documents (ND) which contained registration certificate, specifications & test methods, PIL, primary & secondary packaging, SmPC in country specific language
- Coordinated with Russian delegates during their visits to India to discuss and plan the submission activities for all the concerned CIS countries
- Coordinated with various sites and stakeholders for documents, samples, standards, reagents, columns, and for consignment related documentation (work orders)
- Prepared ASEAN CTD dossier for certain APAC countries (Cambodia, Myanmar, Nepal)
- Prepared Module 2 QOS (Quality Overall Summary) on the basis of Module 3 (Quality) Body of Data as per registration requirements
- Prepared Product development section 3.2.P.2, on basis of source data provided from F & D
- Prepared tender documentation for African countries involving stringent timelines
- Took up the responsibilities of training, monitoring and review of work of junior teammates
Regulatory Affairs Associate - Cipla Ltd.
(2005-12 - 2009-09)
Involved in filing registration dossiers (paper submissions) for mainly LATAM countries.
- Involved in filing registration dossiers (paper submissions) for mainly LATAM countries (Colombia, Bolivia, Ecuador, Peru, and Paraguay)
- Drafted and sent responses to queries and additional document requests for registration dossiers
- Worked on tender projects involving stringent deadlines for the Peru market
- Coordination with the client through email correspondence for registration requirements and HA queries
- Actively coordinated with the manufacturing locations for documents, samples, standards and reagents for registration dossiers submissions and submission related queries or additional documentation requests
- Active coordination with packaging and purchase departments for artworks and labeling requirements as well as consignments related requirements
