Regulatory Affairs Specialist

Job Description:
The Regulatory Affairs Specialist ensures that the organization’s products comply with relevant regulatory requirements and guidelines. They manage the submission, approval, and maintenance of product registrations with regulatory authorities.

Key Responsibilities:

• Prepare and submit regulatory documentation to health authorities, such as FDA, EMA, or other relevant bodies.
• Monitor changes in regulatory guidelines and ensure compliance with industry standards.
• Collaborate with cross-functional teams (e.g., R&D, Quality Assurance, Legal) to provide regulatory support.
• Assist in the preparation of clinical trial applications and post-market surveillance documentation.
• Maintain and update regulatory databases and documentation.
• Provide regulatory guidance during product development and commercialization processes.

Qualifications and Skills:

• Bachelor’s degree in Life Sciences, Pharmacy, or related field.
• Proven experience in regulatory affairs within pharmaceuticals, medical devices, or biotechnology.
• Strong knowledge of global regulatory requirements and standards.
• Excellent communication, analytical, and organizational skills.
• Ability to manage multiple projects and work collaboratively with diverse teams.