Regulatory Affairs Specialist

Full Time
Posted 3 days ago


Job Description:


Ensure compliance with regulatory requirements, standards, and guidelines related to product development, manufacturing, and marketing.

Research, interpret, and monitor regulations, laws, and industry standards applicable to the company’s products and operations.

Prepare and submit regulatory filings, applications, and documentation to regulatory agencies for product approvals, registrations, and certifications.

Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to support regulatory compliance throughout the product lifecycle.

Review and approve labeling, packaging, and marketing materials for compliance with regulatory requirements.

Respond to regulatory inquiries, inspections, and audits from regulatory agencies.

Maintain regulatory files, records, and databases to ensure accuracy and completeness.


Job Requirements:

Bachelor’s degree in Regulatory Affairs, Life Sciences, Chemistry, or related field.

Proven experience in regulatory affairs roles, preferably in the healthcare, pharmaceutical, or medical device industry.

Strong knowledge of regulatory requirements and processes

Excellent analytical, problem-solving, and attention to detail.

Strong communication, interpersonal, and teamwork skills.

Ability to prioritize and manage multiple tasks and deadlines.

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