Regulatory Affairs Specialist

18 hours ago


Navi Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 6,00,000 - ₹ 8,00,000
Regulatory Affairs Specialist

Our organization is seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of US FDA regulations and ICH guidelines.

Key Responsibilities:
• Develop and implement regulatory strategies for new and existing products
• Collaborate with cross-functional teams to ensure compliance with regulatory requirements
• Prepare and submit regulatory documents, including pre- and post-approval submissions
• Conduct regulatory research and stay up-to-date on changes in regulations and guidelines

Requirements:
• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field
• 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting
• Strong understanding of US FDA regulations and ICH guidelines
• Experience in handling pre- and post-approval submissions is required

What We Offer:
• Competitive salary and benefits package
• Opportunities for professional growth and development
• Collaborative and dynamic work environment

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