Associate Director, Regulatory Affairs job in Upper Gwynedd
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|Employer:|| Merck & Co.|
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 Regulatory Affairs Headquarters R4, Associate Principle Scientist supports products in the oncology therapeutic area as part of a regulatory team. He/She will have excellent communication and collaboration skills and will work closely with a global liaison to help develop and implement a global strategy for registration of oncology products and help manage regulatory submissions. His/her responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions. The Associate Principle Scientist will report to a Global Regulatory Liaison (Director or Executive Director) and will work with one or more Regulatory Liaison Directors in the oncology therapeutic area).
The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills.
Specific responsibilities (with coaching and managerial oversight) include but are not limited to:
• Assisting in Regulatory Agency communications and submissions, including but not limited to: marketing applications (sBLAs), requests for orphan drug and/or breakthrough designations and annual or other periodic reports. The individual will also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.
• Implementing strategy to develop Agency background packages and documents associated with Regulatory submissions for marketing applications
• Communicating with Agencies and attending Agency meetings as needed to assist the Global liaison
• Participating as an active member on the global regulatory team. He/She will attend cross functional meetings as required, in collaboration with, and to assist the global liaison.
• Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assist the global liaison in authoring of regulatory strategy documents.
• Collaborating and communicating regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC as well as other functional areas (e.g. clinical research, safety assessment)
• Support of Global liaison in label development
• Assisting with process improvement initiatives
• Performing regulatory administrative activities as needed in support of the oncology TA
Education Minimum Requirement:
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 6 years of relevant experience in the pharmaceutical industry. Alternatively a Master's or other advanced degree with at least 3 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 is required.
• Strong scientific and analytical skills with attention to detail.
Required Experience and Skills:
Prior regulatory experience with any major regulatory agency is required
Preferred Experience and Skills:
Experience in clinical drug development is preferred. 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.
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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