Product lifecycle management: (Domestic and Exports)
Responsible for licensing & registration of pharmaceutical products with DCGI and SLA (state licensing Authority).
Responsible for the online system of submitting applications to State FDA through the respective websites.
Renewal of licenses and preparation of applications for renewal of manufacturing license, renewal of WHO-GMP Certificate, validity & extension of WHO-GMP Certificate, product permissions, Certificate of Pharmaceutical Product (COPP), and Free Sale Certificates (FSC).
Dossier preparation in CTD and manual formats for submission in ASEAN countries and obtaining the registrations.
Responding to post submission queries received on the dossiers submitted to clients and agencies within timelines.
Responsible for reviewing the artworks and giving inputs as per the regulatory guidelines (D&C Act)
Suggestions about artwork design to the marketing team as per the D&C Act.
New Product Launch (Domestic and Exports)
Responsible for Regulatory Filing Strategy inputs with gap analysis once the new product has been identified.
Preparing a response to queries of various agencies.
Study and suggest designs/artworks of market support.
Responsible for New product filings through CTD, ACTD, and regional formats to Health agencies.
One-time product approval and Day-1 launch preparation support.
Information Management, NPPA support, and Plant Audit
Maintain all regulatory documentation and submissions for domestic and international health authorities
Maintain updated information records to keep a track of renewals & license information.
Monitoring closely and keeping a track of all the Pharmaceutical products as per NPPA requirements.
Responsible for Auditing of Manufacturing Plant with respect to quality and regulatory requirements.
Desired Knowledge & Skills:
Experience in managing licensing and registration of pharmaceutical products as per the DCGI and state FDA
Knowledge of New product filing and launches, post-approval filings & renewals of various products for various markets as per the country-specific guidelines.
Ability to inspect, review, and experience in compliance activities during plant audits as per the guidelines
Keeping oneself abreast of changes to the D&C guidelines.
Excellent communication skills (both verbal and written).
Should be a team player with the ability to manage people across departments.
Excellent time management skills.
Adept in the understanding of systems and processes.