Pharma Regulatory Affairs Job at Merck – Apply Online
Specialist – Regulatory Affairs
Job Id 282175
Location: Mumbai, Maharashtra, India
Job Type: Full-time
Title: Specialist – Regulatory Affairs
Location: Mumbai
Purpose of the Role:
Provides overall support to all India-specific and product-related activities. Supports in the preparation of all regulatory submissions planned, communicated, and executed per regulatory and business requirements or any other activity which may be requested depending on the agreed country activity split list.
Job Responsibilities:
- Assists in the maintenance of registrations and licenses of the products in RA systems and databases such as SharePoint and other team folders as necessary.
- Performs labelling reviews and assists in project creation in the Artwork Management system (WebCenter) as needed.
- Ensures timely submission of renewals, site registrations, and minor product submissions to relevant Health Authorities in APAC countries.
- Ensures effective communication across RA (top-down and bottom-up).
- Ensures timely Veeva Vault updates related to LCM activities such as MA renewal, site registration, and other minor product submissions as needed.
- Supports in the request for sample collection via K2 system.
- Generates regional reports, processes vendor payments, and handles other country-related requests.
- Provides support on other country regulatory and cross-functional activities as necessary.
- Conducts timely regulatory intelligence searches in the relevant countries and updates the Country Regulatory Tool system as necessary.
- Takes part in Regional/Global or local hub initiatives that are relevant to support the region and hub.
- Supports the review and revision of hub processes to achieve efficiency across the hub.
Other Activities:
- Strategy Alignment
- For Site Registration submissions only, ensures alignment with the country on submission strategy as required.
- Dossier Readiness
- Performs labelling reviews and assists in project creation in the Artwork Management system.
- Application Submission
- Supports the country in renewal and minor product submissions to relevant Health Authorities.
- Assists overall in the maintenance of registrations and licenses of the products in RA systems and databases.
- For Site Registration submissions only, ensures timely submission/dispatch of the dossier related to submission and timely Veeva Vault updates.
- Application Approval
- Supports the country in renewal and minor product submissions to relevant Health Authorities.
- Assists overall in the maintenance of registrations and licenses of the products in RA systems and databases.
- Product Maintenance
- Assists overall hub in the maintenance of registrations and licenses of the products in RA systems and databases.
- Others
- Provides support on other country regulatory and cross-functional activities.
- Generates reports, requests sample collection, processes vendor payments.
Who You Are:
- Bachelor’s or Master’s in Pharmacy OR D.Pharma
- Minimum 2-3 years of experience in the Indian Regulatory Market
- Fluent in written and spoken English
- Experience in CDSCO, Import, and State FDA
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