We are a global leader in Healthcare, Life Science, and Electronics, committed to enriching lives through innovative science and technology. Our diverse and inclusive workforce thrives on curiosity, collaboration, and a shared passion for making a difference. We believe in empowering our employees to break barriers, innovate, and contribute to meaningful progress in healthcare and beyond.
Job Description
Purpose of the Role
As a Senior Specialist – Regulatory Affairs, you will support India-specific regulatory activities, ensuring compliance with local and international regulations. You will assist in regulatory submissions, license maintenance, labelling reviews, and other critical regulatory functions to facilitate smooth product approvals and lifecycle management.
Key Responsibilities
Regulatory Submissions & Compliance
- Assist in preparing and submitting regulatory filings (renewals, site registrations, minor variations) to CDSCO, State FDA, and other Indian regulatory bodies.
- Maintain product registrations and licenses in RA databases (SharePoint, Veeva Vault, etc.).
- Conduct regulatory intelligence searches and update the Country Regulatory Tool system.
Labelling & Documentation
- Perform labeling reviews and assist in Artwork Management System (WebCenter) projects.
- Ensure timely Veeva Vault updates for renewals, site registrations, and minor submissions.
Cross-functional Collaboration
- Generate regional reports, process vendor payments, and manage sample requests via K2 system.
- Support regulatory and cross-functional activities as needed.
- Participate in regional/global regulatory initiatives to improve efficiency.
Compliance & Strategy
- Ensure alignment with submission strategies for site registrations.
- Assist in dossier preparation, submission, and approval tracking.
- Support product maintenance and regulatory database updates.
Who You Are
- Education: Bachelor’s or Master’s in Pharmacy or related field. PhD is a plus.
- Experience: 5-10 years in Indian Regulatory Affairs, with expertise in CDSCO, Import License, and State FDA regulations.
- Skills:
- Strong knowledge of Indian pharmaceutical regulations.
- Proficiency in regulatory databases (Veeva Vault, SharePoint, WebCenter).
- Excellent communication (written & spoken English) and project management skills.
- Travel:Â Willingness to travel as per business needs.
What We Offer
- A diverse and inclusive workplace fostering innovation and growth.
- Opportunities for professional development in a global regulatory environment.
- A culture that values curiosity, collaboration, and work-life balance.
