Asst Manager/Executive – Regulatory Affairs | Eris Oaknet | Mumbai

Job Description

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.

Desired Skills:

• 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