Merck Associate Director, Regulatory Liaison 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.
The Associate Principal Scientist Regulatory Affairs supports products in the Oncology therapeutic area as part of a regulatory team. The individual will have excellent communication and collaboration skills and will work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidances or competitive intelligence. The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills.
Education Minimum Requirement:
• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline
• Master’s Degree with at least 3 years of relevant experience in pharmaceutical industry.
• Bachelor’s Degree, with at least 6 years of relevant experience in the pharmaceutical industry.
Required Experience and Skills:
• Excellent communication skills (both oral and written).
• Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects
• Flexibility required
• Strong scientific and analytical skills with attention to detail
Preferred Experience and Skills:
Prior regulatory experience interacting with a major regulatory agency is highly preferred. Experience in drug development, particularly oncology products, is highly preferred.
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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Visa sponsorship is not available for this position.
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Job Regulatory Affairs Liaison
Title: Associate Director, Regulatory Liaison
Primary Location: NA-US-PA-Upper Gwynedd
Requisition ID: REG004365
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