Regulatory Consultant (Biotech)

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Requirements:

• Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field; advanced degree preferred.
• 5+ years of experience in regulatory affairs within the biotech industry.
• Demonstrated success in preparing and submitting regulatory applications.
• In-depth knowledge of FDA and EMA regulations, guidance documents, and submission processes.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication abilities.
• Ability to work independently and manage multiple projects simultaneously.
• Proficient in regulatory submission tools and document management systems.
• Regulatory Affairs Certification (RAC) or similar credential is desirable.
• Experience with biologics, gene therapies, or combination products is preferred.

Responsibilities:

• Advise clients on regulatory strategies to achieve compliance with FDA and EMA regulations for biotech products.
• Review and prepare regulatory submissions, including INDs, BLAs, and CTAs.
• Conduct gap analyses to identify areas for improvement in regulatory documentation.
• Assist in the development and execution of responses to regulatory inquiries and actions.
• Stay updated on changes in regulations and industry trends, providing recommendations to clients.
• Prepare and conduct training sessions for client teams on regulatory requirements and best practices.
• Build and maintain strong relationships with clients, fostering trust and collaboration.