Regulatory Affairs cum Quality Assurance
- Job description of regulatory affairs sr.executive
- A Senior Executive – Regulatory Affairs is typically responsible for ensuring that a company's products comply with applicable regulatory requirements and obtaining/maintaining approvals from regulatory authorities. The exact responsibilities vary by industry (pharmaceuticals, medical devices, chemicals, food, cosmetics, etc.), but a typical job description is:
- Senior Executive – Regulatory Affairs
- Job Summary
- The Senior Executive – Regulatory Affairs is responsible for preparing, reviewing, and submitting regulatory documents to government authorities, ensuring compliance with national and international regulations, and supporting product registrations, renewals, and lifecycle management activities.
- Key Responsibilities
- Regulatory Submissions
- Prepare and compile regulatory dossiers for product registrations, renewals, variations, and amendments.
- Submit applications to regulatory authorities and respond to regulatory queries within specified timelines.
- Maintain accurate records of submissions and approvals.
- Compliance Management
- Ensure compliance with applicable regulatory requirements, guidelines, and company policies.
- Monitor changes in regulatory legislation and assess their impact on products and business operations.
- Support internal audits and regulatory inspections.
- Documentation & Review
- Review product labels, packaging materials, promotional literature, and technical documents for regulatory compliance.
- Maintain regulatory databases and document management systems.
- Prepare and review Standard Operating Procedures (SOPs).
- Cross-Functional Coordination
- Collaborate with Quality Assurance, Manufacturing, R&D, Marketing, Supply Chain, and other departments.
- Provide regulatory guidance during product development and commercialization.
- Support product launches by ensuring timely regulatory approvals.
- Authority Interaction
- Liaise with regulatory agencies and external consultants.
- Track application status and follow up with authorities when required.
- Coordinate responses to deficiency letters and regulatory observations.
- Training & Support
- Train internal teams on regulatory requirements and compliance updates.
- Support junior regulatory affairs staff and review their work.
