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Are you ready to contribute to an innovative global company where science and technology are leveraged to improve lives? A Specialist – Regulatory Affairs position is now available in Mumbai, Maharashtra, at a forward-thinking organization that champions diversity, equality, and excellence.
About the Role
As a Specialist in Regulatory Affairs, you will play a crucial role in ensuring regulatory compliance for the organization’s products across India and APAC regions. This role involves maintaining registrations and licenses, supporting cross-functional activities, and contributing to regional and global initiatives.
Key Responsibilities
Regulatory Compliance and Maintenance
- Maintain product registrations and licenses in RA systems such as SharePoint.
- Ensure timely submission of renewals, site registrations, and minor product submissions to health authorities in APAC countries.
- Update Veeva Vault related to life cycle management (LCM) activities.
Project and Process Management
- Conduct labelling reviews and create projects in the Artwork Management System (WebCenter).
- Generate regional reports and handle vendor payments.
- Request sample collections via the K2 system.
Cross-Functional Collaboration
- Facilitate effective communication within Regulatory Affairs (RA) teams.
- Support local regulatory and cross-functional activities.
- Participate in the review and revision of hub processes to enhance efficiency.
Regulatory Intelligence
- Conduct timely regulatory intelligence searches for relevant markets.
- Update the Country Regulatory Tool system.
Candidate Profile
Qualifications
- Bachelor’s or Master’s degree in Pharmacy or D.Pharma.
- Fluency in written and spoken English.
Experience
- 2-3 years of experience in the Indian Regulatory Market.
- Practical knowledge of CDSCO, Import, and State FDA regulations.
Skills
- Strong organizational and analytical skills.
- Effective communication and teamwork capabilities.
- Adaptability to dynamic business needs.
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