Regulatory Affairs Officer

SpinoS Life Science and Research Pvt Ltd is hiring Regulatory Affairs Executives for its Coimbatore, Tamil Nadu operations. This full-time opportunity is suitable for Life Science graduates with 0 to 5 years of experience in regulatory affairs, dossier preparation, compliance management, and pharmaceutical documentation activities. The selected candidate will be responsible for supporting regulatory submissions, maintaining compliance records, coordinating with regulatory authorities, and ensuring adherence to applicable regulations and guidelines. Candidates should possess strong documentation skills, attention to detail, and knowledge of pharmaceutical regulatory requirements. This role offers an excellent opportunity for both freshers and experienced professionals to build expertise in regulatory affairs while contributing to the successful development and commercialization of healthcare products.

Location

Coimbatore, Tamil Nadu, India

Employment Type

Full-time

Experience Required

0 to 5 years

Educational Qualification

Life Science

Key Responsibilities

• Prepare and review regulatory documentation and submissions.
• Maintain compliance records and regulatory databases.
• Support dossier compilation and submission activities.
• Coordinate with internal teams for regulatory requirements.
• Monitor regulatory updates and compliance changes.
• Assist in product registration and approval processes.
• Prepare responses to regulatory queries and observations.
• Ensure document control and data integrity compliance.
• Support audit and inspection readiness initiatives.
• Participate in regulatory process improvement activities.

Required Skills & Competencies

• Knowledge of pharmaceutical regulatory affairs.
• Strong documentation and technical writing skills.
• Attention to detail and accuracy.
• Communication and coordination abilities.
• Understanding of compliance requirements.
• Analytical and problem-solving capabilities.
• Computer proficiency and document management skills.
• Learning mindset and adaptability.
• Time management and organizational skills.
• Commitment to regulatory excellence.

Why Join SpinoS Life Science and Research Pvt Ltd?

SpinoS Life Science and Research Pvt Ltd offers professionals an opportunity to build expertise in regulatory affairs within a growing pharmaceutical organization. The company promotes innovation, continuous learning, and career advancement through exposure to diverse regulatory projects and global compliance practices.