Lumanity
Lumanity is a company focused on enhancing the candidate experience through advanced data collection and privacy policies. They provide a platform for job seekers to engage, upload resumes, and pre-fill application fields, ensuring a seamless application process. Lumanity is committed to improving how candidates interact with potential employers while upholding privacy rights and maintaining anonymity in data usage.
Principal Consultant - Regulatory Strategy
February 10
Lumanity
Lumanity is a company focused on enhancing the candidate experience through advanced data collection and privacy policies. They provide a platform for job seekers to engage, upload resumes, and pre-fill application fields, ensuring a seamless application process. Lumanity is committed to improving how candidates interact with potential employers while upholding privacy rights and maintaining anonymity in data usage.
📋 Description
• We are seeking a highly skilled biotech and pharmaceutical life sciences professional with deep global regulatory expertise to join our Clinical and Regulatory team as a Principal Consultant (Director), Regulatory Strategy • This role is critical in guiding clients through all stages of product development and commercialization and leading regulatory strategies and submissions • The Principal Consultant will also play a key role in business development and sales, thought leadership and brand representation, and team oversight to ensure the delivery of exceptional work
🎯 Requirements
• Advanced degree in a life sciences field (e.g., PhD, MPH, MBA) or regulatory affairs/science is preferred • Extensive experience in regulatory affairs within the pharmaceutical and biotechnology industry, across different types of products (i.e. biologics, drugs, cell/gene therapies), and therapeutic areas (i.e. CNS, oncology, immunology) • Proven track record in project management and regulatory submissions, including experience with regulatory body meetings (e.g., PIND, EOP2, FDA Advisory Committees) • Proficient in scientific/medical data and nomenclature, able to effectively interpret and communicate complex scientific principles • Strong proficiency with Microsoft Word, Outlook, Excel, and PowerPoint • Ability to work independently and collaboratively in a fast-paced environment • Excellent oral and written communication skills, with a passion for presenting scientific data
🏖️ Benefits
• Competitive salary plus bonus scheme • Medical, dental, and vision insurance options • 401(k) plan with employer match • Flexible paid time off program + 10 paid holidays • Flexible spending accounts for health and dependent care • Health savings account option with employer contribution • Employee Assistance Program • Paid short-term and long-term disability coverage • Company-paid life insurance coverage at 1.5x annual salary • Paid parental leave and more
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