Regulatory Affairs Specialist

• Develop and implement regulatory strategies to ensure compliance with applicable laws and industry regulations.
• Prepare, review, and submit regulatory documents, including clinical trial applications, marketing authorizations, and periodic safety update reports.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to ensure alignment with regulatory requirements.
• Conduct thorough reviews of regulatory submissions to identify areas for improvement and recommend enhancements.
• Monitor changes in regulatory requirements and implement plans to maintain compliance.
• Provide training and guidance to internal stakeholders on regulatory affairs best practices and compliance standards.

Job Requirements:

• Extensive knowledge of regulatory requirements in the pharmaceutical or medical device industry.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Ability to work effectively in a collaborative team environment with internal stakeholders.
• Proven project management skills with the ability to prioritize multiple tasks and meet deadlines.
• Experience with regulatory software and systems is an advantage.
• In-depth understanding of Good Clinical Practice (GCP) principles and GxP regulations.
• Educational Qualification: Graduate/Postgraduate degree in relevant field.