Key Responsibilities

Product Research & Development Support

• Conduct product research to ensure new products meet industry, safety, and regulatory requirements.
• Gather and analyze data related to product safety, efficacy, and marketability.

Quality Testing & Documentation

• Oversee batch quality testing to ensure products meet safety, efficacy, and regulatory standards.
• Implement testing protocols, evaluate results, and initiate corrective actions when needed.
• Plan and execute product testing surveys, analyze findings, and ensure all standards are met.
• Maintain complete and accurate records of regulatory submissions, approvals, audits, and testing results.

Regulatory Compliance & FDA Registration

• Manage the full FDA product registration process—from preparation and submission to approval—ensuring full compliance with applicable regulations (pre-market approvals, labeling, post-market surveillance).
• Prepare, submit, and track regulatory documents for product approvals, modifications, and ongoing compliance.
• Review product labels, packaging, and marketing materials to ensure regulatory accuracy and compliance.

Cross-Functional Collaboration

• Work closely with marketing, legal, and other departments to ensure product packaging, communications, and promotions comply with regulatory requirements.
• Provide guidance and training to internal teams on regulatory updates and compliance requirements.

Compliance Monitoring & Risk Management

• Identify regulatory risks in product development and implement corrective and preventive action (CAPA) plans.
• Manage internal and external audits, prepare documentation, address findings, and ensure timely resolution of compliance issues.
• Stay updated on regulatory trends and industry changes, ensuring the company remains fully compliant.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Law, or a related field.
• 2–5 years of experience in regulatory affairs, particularly in FDA registration, product development, and quality testing.
• Strong understanding of FDA regulations, labeling requirements, and post-market compliance.
• Hands-on experience with quality testing and product performance surveys.
• Excellent written and verbal communication skills.
• Strong organizational, analytical, and problem-solving skills with a high attention to detail.
• Proficiency in Microsoft Office and regulatory submission systems.

Preferred:

• Post-graduate training or certifications in Regulatory Affairs (e.g., RAC).
• Experience managing internal/external regulatory audits.