Requisition ID: REG004051
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 Vaccine and Infectious Disease (Anti-Virals) 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 liaison(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.
Activities (with coaching and managerial oversight) include, but are not limited to:
- Assisting in Regulatory Agency communications and submissions, including marketing applications, investigational new drug (IND) applications, pediatric plans and annual or other periodic reports. The individual may 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 regulatory liaison.
- Participating as an active member on the global regulatory team. Individual will attend cross-functional meetings as required, in collaboration with, and to assist the global regulatory liaison.
- Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assist the global regulatory 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, pre-clinical safety assessment).
- Support maintenance (e.g., quality compliance and life cycle management) of VID programs.
- Support of global regulatory liaison in label development.
- Assisting with process improvement initiatives.
- Performing regulatory administrative activities as needed .
Education Minimum Requirement:
- MD 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 anti-infectives and/or vaccine 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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Job: Regulatory Affairs Liaison
Other Locations: Rahway, NJ, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: None
Company Trade Name: Merck