Merck Senior Specialist, Regulatory Affairs in Upper Gwynedd, Pennsylvania
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
This position is in the Oncology team within Regulatory Affairs International HQ.
The Regulatory Affairs International Headquarters (RAI-HQ) R3, Senior Scientist position is a broad role encompassing all aspects of regulatory strategy including Chemistry, Manufacturing and Controls (CMC), clinical efficacy, safety, risk management, and labeling. He/She has direct responsibility for a portfolio of products that generally ranges across all phases of development and includes mature products. The Senior Scientist reports to a Director in RAI-HQ.
The Senior Scientist will have responsibility for an assigned portfolio of products. The individual will have responsibility for leading and strategically driving results on assigned products and projects through alignment and prioritization with Department management and across stakeholders.
Specific responsibilities (with coaching and managerial oversight) include:
• Create and drive implementation of a Rest of World (ROW) regulatory strategy for assigned new products to optimize time to approval in collaboration and alignment with the product team.
• Create and drive execution of regulatory strategy to support lifecycle management of In-line (i.e. mature) products.
• Occasionally review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues.
• Regulatory review of labeling and responsibility for the strategy and release of supplemental safety and efficacy supplements to update the label.
• Collaborate and communicate with Country Regulatory Leads, Regional Leads, Regional Liaisons, other functional areas within Global Regulatory Affairs and Clinical Safety, MRL and across Divisions with GHH and MMD to ensure alignment around a common set of priorities and objectives for ROW filings and lifecycle management activities.
• Support for Clinical Trial Applications (CTA’s) in Phase I-III, Product, Registration and Launch (PR&L) filings, and post filing activities.
• Participate in business process space forums and other organizational initiatives and may represent RAI HQ on cross-functional/cross-divisional teams
• Act as the Global Regulatory Team (GRT) Lead for assigned products
• May have some agency interactions such as facilitating responses to agency queries, Pre-Submission Meetings (PSMs), FDA communications, etc.
Previous industry experience is required. Depending upon previous work experience, a new Senior Scientist may require close managerial oversight and guidance as they gain and accumulate knowledge and gain exposure to programmatic regulatory issues.
Degree in Pharmacy, Biological Science, Chemistry, Nursing or related discipline.
• Bachelor’s degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with at least 4 years of relevant experience in the pharmaceutical industry. Alternatively a Master’s or other advanced degree with at least 2 years of relevant experience in pharmaceutical industry.
• Must have excellent communication skills (both oral and written)
• Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
• Flexibility and negotiating skills are required.
• Strong scientific and analytical skills.
• Prior regulatory experience is preferred but not required.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job Regulatory Affairs Liaison
Other Locations: NA-US-NJ-Rahway
Title: Senior Specialist, Regulatory Affairs
Primary Location: NA-US-PA-Upper Gwynedd
Requisition ID: REG004532
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