Urgent Regulatory Specialist

4 weeks ago

Hyderabad, Telangana, India Freyr Solutions Full time
Looking for a Senior Reg. Management Professional with 5+ years of hands-on experience in managing Regulatory Data for day-to-day registration. The ideal candidate must have 4+ years of experience in Regulatory data management within the Pharma domain. This role involves working closely with business stakeholders to track & manage registration data in the database, able to find the gaps in process, ensure lifecycle management, and strengthen business decision-making.

Key Responsibilities:

- Regulatory Product Lifecycle management in Veeva Vault.
- Interpreting Health Authority requirement into Database requirement
- Understanding Health authority Guidelines and suggesting the appropriate resolution to the change concerned
- Experience working GxP environment

Required Skills & Experience:

- 5-7 years of experience with at least,
- 5+ years Regulatory Data Management.
- 3+ years of experience in Pharma Industry
- Expertise in Reg. Mang. Database handling
- Experience with project management methodologies and working in a collaborative team environment.
- Strong self-investigating attitude and ability to work independently.
- Exp. With quality & compliance processes, GxP guidelines, xEVMPD & IDMP knowledge
- Veeva Vault Certification

Preferred Qualifications:

- Master in Phrama/Biological Sc.
- Veeva Vault Certification.
- Experience in translating Business knowledge to IT/Data Requirement for any development.
- Experience working in JIRA/SharePoint/ServiceNOW.

Industry Experience:

- Experience with Veeva Vault application.
- Experience in Regulatory Ops. & Product Lifecycle management.

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