Regulatory Affairs Project Manager

October 15

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Alira Health

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Nuclear medicine • Rare disease • Lupus • Myasthenia gravis • Robotics

501 - 1000 employees

⚕️ Healthcare Insurance

💰 $58M Venture Round on 2023-01

Description

• Manage various projects for Alira Health clients with support of Senior regulatory experts • Support clients in broad range of drug development activities from early to late stage of development • Ensure timely delivery of high-quality documents and best regulatory strategy • Contribute to shaping the regulatory department to make it best in class • Develop and lead regulatory activities for projects • Prepare and submit packages for regulatory agencies

Requirements

• 5-year degree in a scientific discipline (Pharmaceutical Science, Chemistry, Biology) • At least 6-8 years' regulatory affairs experience either in regulatory affairs consulting or in pharmaceutical industry or in biotech company • Expertise in early development program including gap analyses, EU scientific advice (national and EMA); US FDA meetings, preparation & submitting clinical trials application • Experience in NDA/BLA/MAA, IND/CTA • Experience in orphan drug designation, pediatric procedure • Experienced in small molecules/biologicals • Expertise in radioligand or ATMP will be a plus • Excellent verbal and written English communication and writing skills (knowledge of second language would be an asset) • Organizational skills and regulatory project management skills, ability to successfully manage multiple projects to deadlines • Committed to continuous improvement

Benefits

• professional development • global travel • flexible work programs • more