Senior Principal Scientist, Regulatory Liaison

Job not on LinkedIn

🔥 17 minutes ago

🏖️ New Jersey, Massachusetts, +1 more states – Remote

🏖️ New Jersey – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote

💵 $190.8k - $300.3k / year

⏰ Full Time

🟠 Senior

🧬 Research Scientist

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Develop and implement worldwide regulatory strategies for assigned General Medicine projects, with a focus on Immunology development programs • Provide regulatory oversight to optimize product labeling and obtain the shortest time to approval from global regulatory agencies • Independently manage projects as the accountable global point of contact for project teams • Interact with worldwide regulatory agencies and subsidiaries regarding global regulatory strategy and registration requirements • Use regulatory and competitive landscapes to establish strategies that facilitate speed-to-market and targeted product labeling • Serve as Global Regulatory Lead and regulatory single point of contact throughout product life cycles • Lead Global Regulatory Teams coordinating cross-functional regulatory support • Coordinate preparation, submission, and follow-up communications with regulatory agencies • Review global applications and associated documentation • Review and provide final approval of local registration study protocols for secondary markets • Lead regulatory meetings, teleconferences, and written communications with agencies including FDA and EMA • Lead cross-functional preparation for FDA advisory committees • 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

🎯 Requirements

• B.S. or M.S. with a minimum of 10 years of relevant drug development experience, with the majority in regulatory, OR M.D. or PhD/PharmD with a minimum of 7 years of relevant drug development experience, including five years in regulatory • Experience leading or supporting direct interactions with major Health Authorities, such as FDA and EMA • Expertise leading regulatory strategies across global regions • Global regulatory affairs experience in major markets: U.S., EU, Japan, and China • Strategic thinking, problem-solving, and continuous learning mindset • Effective written and verbal communication, with ability to influence, lead, and negotiate across levels and functions • Leadership experience building and leading high-performing teams or projects • Corporate and ethical integrity • Preferred: therapeutic area expertise in immunology • Preferred: small and large molecule experience • Preferred: prior people management experience • Required skills: Drug Development, Global Regulatory, Pharmaceutical Industry, Pharmaceutical Research, Product Registrations, Regulatory Affairs Management, Regulatory Communications, Regulatory Documents, Regulatory Processes, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Strategic Leadership • US and Puerto Rico residents only • No visa sponsorship

🏖️ 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 days • Sick days • Remote work arrangement