Job Title: Senior Specialist - Regulatory Affairs
Job Summary
We are hiring a Senior Specialist - Regulatory Affairs for our Mumbai location. The role focuses on regulatory documentation, license maintenance, labeling reviews, and timely submissions to Health Authorities across APAC. Ideal candidates will have strong knowledge of Indian regulatory frameworks such as CDSCO, Import, and State FDA processes. This is a full-time opportunity to grow in a dynamic, global healthcare environment.
Key Responsibilities
Maintain product registrations and licenses in regulatory systems like SharePoint and team databases.
Perform labeling reviews and assist in project creation using the Artwork Management System (WebCenter).
Ensure timely submission of renewals, site registrations, and minor product updates to APAC Health Authorities.
Update Veeva Vault for activities such as Marketing Authorization (MA) renewals and site registrations.
Support country-specific regulatory and cross-functional activities, including sample collection requests via K2 system and vendor payment processing.
Conduct regulatory intelligence searches and update the Country Regulatory Tool system.
Generate regional regulatory reports and assist with country-specific regulatory submissions.
Contribute to regional or global hub process improvement initiatives and cross-functional support.
Required Skills & Qualifications
Bachelor’s/Master’s degree in Pharmacy or Ph.D. in a relevant field.
Minimum 5–10 years of experience in the Indian Regulatory Market.
Strong knowledge of CDSCO, Import regulations, and State FDA requirements.
Fluent in spoken and written English.
Experience with Veeva Vault, K2 system, and SAP-based regulatory tools is an advantage.
Excellent communication and organizational skills.
Perks & Benefits
Opportunity to work with a leading global healthcare company.
Diverse and inclusive workplace culture.
Professional growth and career advancement opportunities.
Exposure to global regulatory processes.
Comprehensive employee benefits package (details not specified).
Company Description
A global leader in Healthcare, Life Science, and Electronics, the company is committed to delivering innovative solutions that improve lives worldwide. It fosters a diverse, inclusive, and collaborative work culture that encourages scientific curiosity and progress.
Work Mode
On-site (Mumbai, India)
Salary/Compensation
Not specified in the job description.
Call to Action
Are you an experienced Regulatory Affairs professional ready to drive global healthcare compliance and innovation? Apply now to become part of a diverse and dynamic team shaping the future of life sciences.
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