Director, Regulatory Affairs Liaison, Vaccines – Infectious Diseases

Job not on LinkedIn

🕒 July 29

🏖️ New Jersey, Maryland, +2 more states – Remote

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

💵 $210.4k - $331.1k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 global regulatory strategy for assigned Vaccines and Infectious Disease projects • Provide regulatory oversight and serve as the single accountable global regulatory point of contact • Develop worldwide product regulatory strategy to optimize labeling and obtain the shortest time to approval • Advise Product Development Teams and subsidiaries on regulatory issues throughout the drug life cycle • Lead the Global Regulatory Team coordinating cross-functional regulatory support • Represent the company in communications and meetings with the FDA • Prepare company teams for FDA meetings at all phases of drug development • Lead cross-functional preparation for advisory committees and potentially speak at advisory committees • Coordinate interactions with foreign agencies through Regulatory Affairs Europe and subsidiary registration departments • Review and provide final approval of worldwide marketing applications, clinical study reports, protocols, and investigator brochures • Represent Global Regulatory Affairs on internal committees and provide regulatory advice and approvals • Conduct initial IND/Clinical Study Agreement content review and approval • Participate in regulatory due diligence for licensing candidate reviews • Work with business development partners on regulatory responsibilities for developmental compounds and marketed products

🎯 Requirements

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry, or related discipline • Alternatively, master's degree with substantial regulatory affairs experience suggesting equivalent ability • M.D. with minimum of 3 years relevant drug development or clinical experience, or Ph.D. with minimum of 5 years relevant drug development experience, or M.S. with minimum of 7 years relevant drug development or clinical experience • Excellent oral and written communication skills • Good organizational skills and proven ability to balance diverse activities or multiple projects simultaneously • Flexibility • Strong scientific and analytical skills with attention to detail • Ability to achieve optimal results with limited day-to-day direction • Substantial experience in regulatory affairs preferred • Experience in vaccines or infectious diseases preferred • Experience with antibacterial, antifungal, or antiviral agents preferred • No visa sponsorship • Valid driving license: No

🏖️ Benefits

• Annual bonus eligibility • 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