Distinguished Scientist, Regulatory Liaison

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🔥 2 minutes ago

🏖️ New Jersey, Maryland – Remote

🏖️ New Jersey – Remote 🦀 Maryland – Remote

💵 $231.9k - $365k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

🦅 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 oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products • Provide strategic and tactical CDx/IVD regulatory guidance to product development teams, regulatory liaisons, and senior leaders • Manage regulatory activities related to development, registration, approval, and lifecycle management of companion diagnostics and other IVD products • Provide regulatory leadership for complex programs or major components of high-priority programs • Assess the impact of diagnostic and drug regulations on diagnostic development, clinical development, and global registration strategies • Review regulatory strategies and ensure plans are scientifically sound, compliant, and aligned with development objectives • Identify regulatory risks and develop pragmatic approaches supporting compliance, objectives, and timelines • Collaborate across organizational and geographic boundaries to resolve regulatory issues • Manage senior stakeholders and communicate program risks, regulatory issues, and mitigation strategies • Lead regulatory interactions with external diagnostic partners • Oversee or contribute to diagnostic regulatory submissions, including IDEs, PMAs, 510(k)s, pre-submission materials, and other filings • Lead or support interactions with regulatory authorities, including briefing documents, meeting strategies, and agency meetings • Review and approve regulatory communications, background packages, and submission materials • Review labeling and manage labeling negotiations with regulatory authorities • Support global development and registration activities with international colleagues and diagnostic partners • Participate in regulatory due diligence involving partners, development agreements, licensing opportunities, and external products or technologies • Support external scientific and regulatory engagement, policy, and advocacy activities • Monitor regulatory developments and represent the company in external initiatives and regulatory-authority interactions • Lead and manage a team of regulatory professionals • Assign regulatory liaisons, manage resources and priorities, recruit and onboard staff, and provide coaching, mentoring, performance management, development planning, and career guidance • Establish expectations and promote consistent regulatory practices • Foster an inclusive, collaborative environment promoting scientific rigor, accountability, and cross-functional partnership

🎯 Requirements

• Bachelor’s degree in a biological science, chemistry, engineering, regulatory science, or a related discipline, with a minimum of 12 years of relevant drug-development or regulatory experience, including substantial experience in regulatory affairs; or master’s degree with a minimum of 10 years of relevant experience; or doctoral degree with a minimum of 7 years of relevant experience • Significant regulatory experience in companion diagnostics and/or in vitro diagnostics • Demonstrated knowledge of diagnostic product development and regulatory requirements applicable to companion diagnostics and IVDs • Experience developing regulatory strategies and supporting regulatory submissions for diagnostic products • Experience interacting with the U.S. Food and Drug Administration or other regulatory authorities • Strong scientific knowledge, professional credibility, and familiarity with regulatory requirements across relevant global markets • Ability to interpret evolving regulatory requirements and apply them to complex development programs • Ability to develop creative and pragmatic regulatory strategies for complex or unprecedented issues • Experience leading high-performing teams or projects and managing multiple priorities in a matrixed environment • Ability to communicate complex scientific and regulatory issues clearly and effectively to senior leaders, development teams, diagnostic partners, and regulatory authorities • Outstanding written, verbal, interpersonal, negotiation, and presentation skills • Strong organizational skills, sound judgment, and ability to work independently while maintaining effective collaboration across functions • Demonstrated leadership attributes, including relationship building, influencing decisions, constructive conflict management, and developing regulatory professionals • No visa sponsorship

🏖️ Benefits

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

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