Principal Scientist, Regulatory Liaison – Immunology

Job not on LinkedIn

🔥 18 hours ago

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

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

💵 $173.2k - $272.6k / year

⏰ Full Time

🔴 Lead

🧬 Research Scientist

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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 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