Principal Scientist, Regulatory Liaison – Immunology

Job Description:

• Develop worldwide product regulatory strategies for assigned indications to optimize labeling and obtain the shortest time to approval
• Assess regulatory and competitive landscapes to establish global regulatory strategies that facilitate speed-to-market and targeted product labeling
• Provide expert advice as Global Regulatory Lead to Product Development Teams
• Serve as the regulatory point of contact for products within and external to GRACS throughout the drug life cycle
• Lead the Global Regulatory Team coordinating cross-functional regulatory support for development programs and marketed products
• Coordinate preparation, submission, and follow-up with regulatory agencies and subsidiaries for applications and submissions
• Conduct regulatory review and final approval of submissions and associated documentation
• Review and provide final approval of local registration study protocols when needed for marketing authorization in secondary markets
• Interact independently with regulatory agencies including FDA and EMA through meetings, teleconferences, and written communications
• Coordinate regional regulatory strategy and submissions with Regulatory Affairs Europe and local affiliate teams
• Review worldwide marketing applications, clinical study reports, protocols, and investigator brochures
• Prepare INDs/CTAs for global studies involving investigational drugs and biologics
• Participate in regulatory due diligence for licensing candidate reviews
• Independently manage complex projects as the accountable global point of contact

Requirements:

• B.S. or M.S. with a minimum of 7 years of relevant drug development experience, with the majority in regulatory, OR M.D. or PhD/PharmD with a minimum of 5 years of relevant drug development experience, including three years in regulatory
• Strong strategic thinking, problem-solving, and continuous learning mindset
• Effective written and verbal communication skills
• Ability to influence, lead, and negotiate across levels and functions
• Experience leading or supporting direct interactions with major Health Authorities, such as FDA and EMA
• Demonstrated expertise leading regulatory filings across global regions
• Therapeutic area expertise in immunology preferred
• Small and large molecule experience preferred
• Regulatory affairs experience in major markets (U.S., EU, Japan, China) preferred
• Experience in drug development, global regulatory, pharmaceutical industry, pharmaceutical research, product registrations, regulatory affairs management, regulatory communications, regulatory processes, regulatory strategies, regulatory submissions, and strategic leadership
• Immunology preferred
• US and Puerto Rico residency eligibility stated
• No visa sponsorship available

Benefits:

• Annual bonus
• Long-term incentive, if applicable
• Medical, dental, and vision healthcare
• Other insurance benefits for employee and family
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days
• Remote work arrangement