Regulatory Affairs Specialist

both internal teams and external stakeholders to ensure regulatory compliance and smooth operational workflows.

Key Responsibilities:

Develop and implement procedures to ensure regulatory compliance across all functions.

Lead the Regulatory and Quality departments by building systems, competencies, and structure.

national and international regulations and guidelines.

Regulatory/Quality and other teams from product planning to government approvals.

license applications, renewals, and clearances.

oversee accurate submission documentation in collaboration with principals and distributors for domestic and international registrations.

(CDSCO, DGHS, DAHD, DCA, FSSAI, CPCB, etc.).

ensure compliance with regulatory and QMS standards.

including FSCA, complaint handling, recalls

Review promotional material and packaging for regulatory compliance.

regulatory documentation, specifications, and internal SOPs.

Conduct regular training for the team across divisions to comply with regulatory requirements as per company requirements on Regulatory Domain.

timely registration and licensing of all products and instruments.

Approve Purchase Orders

Skills & Competencies:

(CDSCO, DGHS, IVD regulations,

licensing, audits, product registrations, and compliance documentation.

Ability to interpret and implement regulatory requirements effectively.

Strong communication and stakeholder management skills.

Proficiency in preparing regulatory documentation and coordinating with government authorities.

Attention to detail and excellent organizational skills.

QMS implementation and compliance.

legal metrology, labeling, and MRP compliance.

Qualification:

Degree in BPharm / M.Pharma / Biotech or any Biological Sciences with a strong knowledge and experience of regulatory domain.

Experience:

3-7 years experience

CDSCO Department