High Salary Senior Specialist- Regulatory Affairs

2 weeks ago

Mumbai, Maharashtra, India Merck Sharp Dohme Msd Full time
Job Description

Job Summary:

The Regulatory Affairs Specialist will provide end-to-end regulatory support for India-specific and APAC product-related activities. The role ensures timely and accurate execution of regulatory submissions, maintenance of product licenses, and coordination with Health Authorities (e.g., CDSCO, State FDA). This position requires strong experience in India's regulatory landscape, excellent organizational skills, and the ability to work collaboratively with cross-functional and global teams.

Key Responsibilities:

1. Regulatory Submissions & Product Maintenance

- Prepare, compile, and support regulatory submissions (renewals, site registrations, and minor variations) for India and APAC countries.
- Assist in maintenance of registrations and product licenses in regulatory systems (e.g., Veeva Vault, SharePoint, internal databases).
- Support labeling review and project creation in the Artwork Management System (WebCenter).
- Ensure timely dispatch and tracking of dossiers for regulatory applications.

2. Regulatory Systems & Documentation

- Maintain up-to-date records of submissions and approvals in regulatory systems.
- Perform regular updates in Veeva Vault related to life cycle management (LCM) activities.
- Assist with generation of regional and local regulatory reports.

3. Cross-functional & Operational Support

- Coordinate sample requests through internal platforms (e.g., K2 system).
- Support vendor payments and country-specific administrative tasks.
- Facilitate communication within the RA team (top-down and bottom-up) and with other internal functions.

4. Regulatory Intelligence & Process Improvement

- Conduct regulatory intelligence searches and maintain country-specific updates in the Country Regulatory Tool system.
- Participate in regional/global/local process improvement initiatives and support harmonization of hub procedures.
- Assist in the review and refinement of internal RA processes to improve efficiency.

5. Stakeholder Engagement & Strategic Alignment

- Align with internal stakeholders and country RA teams on submission strategies for India and APAC.
- Collaborate with global RA counterparts to ensure alignment with corporate policies and timelines.

6. Additional Responsibilities

- Provide support for CDSCO, Import Licensing, and State FDA requirements.
- Represent Regulatory Affairs in cross-functional meetings when required.
- Travel as needed to support business requirements.

Qualifications & Requirements:

- Educational Background:
- Bachelor's or Master's degree in Pharmacy, or PhD in a related field.
- Experience:
- Minimum 510 years of experience in Indian Regulatory Affairs.
- Strong working knowledge of CDSCO, Import Registration, and State FDA regulations.
- Experience working with APAC regulatory submissions is a plus.
- Technical Skills:
- Proficient in Veeva Vault, SharePoint, Artwork Management Systems, and regulatory documentation platforms.
- Familiarity with tools like K2, vendor payment systems, and document tracking tools.
- Soft Skills:
- Excellent verbal and written communication in English.
- Strong organizational, analytical, and problem-solving skills.
- Ability to manage multiple tasks simultaneously and work independently.
- A collaborative team player with a proactive mindset.

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