Officer/Sr. Officer-Regulatory Affairs
3 - 5 Years of ExperienceNot disclosed Full Time
Fresenius Kabi Oncology Limited
Kalyani, West Bengal, India
Posted on 12-12-2024
149 Views
1 Vacancy
Description
- Prepare and submit regulatory documents and applications to ensure compliance with local and international regulatory agencies.
- Monitor and interpret changes in regulatory laws and guidelines to ensure the company's products remain compliant.
- Maintain up-to-date knowledge of regulatory requirements for various markets (domestic and international).
- Coordinate with product development and quality teams to ensure products meet regulatory standards.
- Review and approve labeling, packaging, and promotional materials to ensure they comply with regulatory guidelines.
- Manage and track product registrations, licenses, and certifications, ensuring timely renewals.
- Act as a liaison between regulatory agencies and internal teams, addressing inquiries and concerns.
- Support regulatory audits and inspections, ensuring documentation and processes are in line with regulatory expectations.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Key Skills
CommunicationAttention to DetailDecision MakingPositive Attitude
Aggregated job.
Learn more