A globally renowned organization, we foster a culture of inclusivity, innovation, and collaboration, empowering curious minds to turn the unimaginable into reality. Join us and become part of a team that’s passionate about driving positive change across the planet, people, and industries.
Job Responsibilities
Core Duties
- Maintain registrations and licenses for products in regulatory systems such as SharePoint and other databases.
- Perform labeling reviews and support project creation in the Artwork Management System (WebCenter).
- Submit timely renewals, site registrations, and minor product applications to relevant health authorities in APAC countries.
- Update regulatory systems like Veeva Vault for lifecycle management (LCM) activities, including MA renewals and site registrations.
- Assist with sample collection via the K2 system and process vendor payments.
- Conduct regulatory intelligence searches and update the Country Regulatory Tool system as needed.
- Generate regional reports and provide cross-functional support for country-specific regulatory activities.
Strategic Support
- Align submission strategies for site registration with country-specific regulations.
- Facilitate application submissions and approvals by assisting with documentation and maintaining databases.
- Review and refine hub processes to enhance efficiency and support regional/global initiatives.
Qualifications
- Education: Bachelor’s or Master’s in Pharmacy, or D.Pharma.
- Experience: 2-3 years in the Indian Regulatory Market, with expertise in CDSCO, Import, and State FDA processes.
- Language: Proficient in written and spoken English.
Skills Required
- Technical Expertise: In-depth knowledge of regulatory frameworks, including CDSCO and FDA compliance.
- Analytical Thinking: Ability to manage data in regulatory systems and generate accurate reports.
- Communication: Strong interpersonal and written communication skills for cross-functional collaboration.
- Attention to Detail: Precise in maintaining product registrations and licenses.
- Adaptability: Willingness to travel for business needs and participate in regional initiatives.
