Date PostedJune 7, 2023
Location (State / UT)
Expiration dateApril 10, 2024
Experience3 Years, 8 Years
Desired QualificationMaster’s Degree, Bachelor Degree
Key Deliverables of the Job:
Product lifecycle management: (Domestic and Export)
- Responsible for licensing & registration of pharmaceutical products with DCGI and SLA (state licensing Authority).
- Responsible for the online system of submitting applications to the 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 Export)
- Responsible for Regulatory Filing Strategy inputs with gap analysis once the new product has been identified.
- Preparing a response to queries from 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 track of renewals & license information.
- Monitoring closely and keeping track of all the Pharmaceutical products as per NPPA requirements.
- Responsible for Auditing of Manufacturing plants with respect to quality and regulatory requirements.
KNOWLEDGE AND SKILL REQUIREMENTS”
- Experience in managing licensing and registration of pharmaceutical products as per the DCGI and state FDA
- Knowledge of New products 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 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