Regulatory Affairs Executive

Key Responsibilities

• Prepare and submit regulatory dossiers for emerging markets, including Brazil, China, and LATAM.
• Participate in deficiency meetings, review pending deficiencies, and collaborate with cross-functional teams to ensure timely submission of responses.
• Manage and evaluate international regulatory projects in alignment with company goals.
• Plan, coordinate, and submit regulatory dossiers and responses in regulated markets.
• Review documents, identify gaps, ensure compliance, and facilitate acceptance meetings.
• Plan amendments, updates, and annual reports, ensuring accurate compilation, review, and submission.

Qualifications & Skills

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
• 3-8 years of experience in regulatory affairs within the API/pharmaceutical industry.
• Understanding of global regulatory requirements, dossier preparation, and submission processes.
• Strong analytical skills to identify and resolve regulatory gaps.
• Ability to collaborate with internal teams and regulatory authorities effectively.
• Experience in handling multiple regulatory projects and ensuring timely submissions.