Merck KGaA

Senior Specialist- Regulatory Affairs

Posted On

March 5, 2025

Location

Mumbai, Maharashtra

Experience Level

D - Professional (4-9 years)

Job Type

Full-time

Apply By

March 25, 2025

Job Description

Title: Senior Specialist - Regulatory AffairsLocation: 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 maybe requested depending on agreed country activity split list. Job Responsibilities:• Assists in the maintenance of registrations and licenses of the products in RA systems and database such as SharePoint and other team folders as necessary. • Performs labelling reviews and assisting in project creation in the Artwork Management system (WebCenter) as needed.• Ensures timely submission of in renewal, site registrations and minor product submissions to relevant Health Authorities in APAC countries.• Ensures effective communication across RA (top-down and botom-up)• Ensures timely Veeva Vault update related to LCM activities such as MA renewal, site registration, and other minor product submissions as needed.• Supports in the request of samples collection via K2 system.• Generates regional reports, process vendor payments and other country-related requests.• Provides support on other country regulatory and cross functional activities as necessary.• Conducts timely regulatory intelligence search in the relevant countries and update 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 hub.Able to travel as per business need. Other Activities:a) Strategy Alignment -For Site Registration submissions only, ensures alignment with country on submission strategy as required.b) Dossier Readiness - Performs labelling reviews and assists in project creation in Artwork Management system.c) Application Submission- Supports country in renewal and minor product submissions to relevant Health Authorities.- Assists overall the maintenance of registrations and licenses of the products in RA systems and database.- For Site Registration submissions only, ensures timely submission/dispatch of the dossier related to submission and timely Veeva Vault updates.d) Application Approval- Supports country in renewal and minor product submissions to relevant Health Authorities.- Assists overall maintenance of registrations and licenses of the products in RA systems and database.e) Product Maintenance- Assists overall hub in the maintenance of registrations and licenses of the products in RA systems and database.f) Others- Provides support on other country regulatory and cross functional activities.- Generates reports, request samples collection, process vendor payments Who you are:Bachelors or Masters in Pharmacy OR p.HDMin 5-10 Years of experience in Indian Regulatory Market Fluent in written and spoken EnglishExperience in CDSCO, Import and State FDA We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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