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Associate Director Regulatory Affairs

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Gwynedd, PA

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u003Cbu003ERequisition ID: u003C/bu003EREG003759u003Cbr/u003Eu003Cbr/u003Eu003CP style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003CFONT size=2 face=Arialu003EMerck u0026amp; 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 itsu0026nbsp;u003C/FONTu003Eu003CFONT face=arialu003Eu003CFONT size=2u003Elegacy for over a centuryu003C/FONTu003Eu003C/FONTu003Eu003CFONT size=2 face=Arialu003E. Mercku2019s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.u003C/FONTu003Eu003C/Pu003Eu003CP style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003CFONT size=2 face=Arialu003Eu003CBRu003Eu003C/FONTu003Eu003CFONT face=Arialu003Eu003CFONT size=2u003EMerck is on a quest for cures and is committed to being the worldu2019s premier, most research-intensive biopharmaceutical company. Today, weu2019re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Mercku2019s leading discovery capabilities and world-class small molecule and biologics Ru0026amp;D expertise to create breakthrough science that radically changes the way we approach serious diseases.u0026nbsp;u003C/FONTu003Eu003C/Pu003Eu003CDIVu003Eu003CTABLE class= FCK__ShowTableBorders cellSpacing=0 cellPadding=0 align=center vspace= hspace=\u003Eu003CTBODYu003Eu003CTRu003Eu003CTD vAlign=top align=leftu003Eu003CDIVu003Eu003CFONT color=black size=2 face=Arialu003Eu003C/FONTu003Eu0026nbsp;u003C/DIVu003Eu003CDIVu003Eu003CFONT size=2u003Eu003CFONT color=black face=Arialu003EThe Regulatory Affairs Headquarters Associate Principal Scientist supports products in the vaccine and infectious disease (VID) therapeutic area as part of a regulatory team.u0026nbsp; He/She will have excellent communication and collaboration skills and will work closely with a global liaison(s) to help develop and implement a global strategy for registration and/or maintenance of VID u003C/FONTu003Eu003CFONT face=Arialu003Eproducts.u0026nbsp; u003CFONT color=blacku003EResponsibilities 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.u0026nbsp; u003C/FONTu003EThe Associate Principal Scientist will reportu003CFONT color=blacku003E to a Global Regulatory Liaison (Director or Executive Director) and will work with one or more Regulatory Liaison Directors in the VID therapeutic area).u0026nbsp; u003C/FONTu003Eu003C/FONTu003Eu003C/FONTu003Eu003C/DIVu003Eu003CDIVu003Eu003CTABLE class= FCK__ShowTableBorders cellSpacing=0 cellPadding=0 align=center vspace= hspace=\u003Eu003CTBODYu003Eu003CTRu003Eu003CTD vAlign=top align=leftu003Eu003CDIVu003Eu003CFONT color=black size=2 face=Arialu003Eu003C/FONTu003Eu0026nbsp;u003C/DIVu003Eu003CDIVu003Eu003CFONT color=black size=2 face=Arialu003EThe individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills.u0026nbsp;u0026nbsp;u0026nbsp; u003C/FONTu003Eu003C/DIVu003Eu003CDIVu003Eu003CFONT color=black size=2 face=Arialu003Eu0026nbsp;u003C/FONTu003Eu003C/DIVu003Eu003CDIVu003Eu003CFONT color=black size=2 face=Arialu003ESpecific responsibilities (with coaching and managerial oversight) include but are not limited to: u003C/FONTu003Eu003C/DIVu003Eu003CULu003Eu003CLIu003Eu003CFONT face=Arialu003Eu003CFONT size=2u003EAssisting in Regulatory Agency communications and submissions, including but not limited to: marketing applications, INDs, 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 requestsu003CFONT color=blacku003E.u003C/FONTu003Eu003C/FONTu003Eu003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT size=2 face=Arialu003EImplementing strategy to develop Agency background packages and documents associated with Regulatory submissions for marketing applications u003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT size=2 face=Arialu003ECommunicating with Agencies and attending Agency meetings as needed to assist the global liaisonu003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT color=black size=2 face=Arialu003EParticipating as an active member on the global regulatory team.u0026nbsp; He/She will attend cross-functional meetings as required, in collaboration with, and to assist the global liaison.u003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT color=black face=Arialu003Eu003CFONT color=blacku003Eu003CFONT size=2 face='arial, sans-serif'u003EConducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy.u0026nbsp; Assist the global liaison in authoring of regulatory strategy documents.u003C/FONTu003Eu003C/FONTu003Eu003CFONT face='arial, sans-serif'u003Eu003C?xml:namespace prefix = o ns = urn:schemas-microsoft-com:office:office /u003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT color=black face=Arialu003Eu003CFONT color=blacku003Eu003CFONT size=2 face='arial, sans-serif'u003ECollaborating 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)u003C/FONTu003Eu003C/FONTu003Eu003CFONT face='arial, sans-serif'u003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT color=black face=Arialu003Eu003CFONT color=blacku003Eu003CFONT size=2 face='arial, sans-serif'u003ESupport maintenance (e.g., quality compliance and life cycle management) of VID programsu003C/FONTu003Eu003C/FONTu003Eu003CFONT face='arial, sans-serif'u003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT color=black face=Arialu003Eu003CFONT color=blacku003Eu003CFONT size=2 face='arial, sans-serif'u003ESupport of Global liaison in label developmentu003C/FONTu003Eu003C/FONTu003Eu003CFONT face='arial, sans-serif'u003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT color=black face=Arialu003Eu003CFONT color=blacku003Eu003CFONT size=2 face='arial, sans-serif'u003EAssisting with process improvement initiativesu003C/FONTu003Eu003C/FONTu003Eu003CFONT face='arial, sans-serif'u003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT color=black size=2 face=Arialu003Eu003CFONT color=blacku003Eu003CFONT face='arial, sans-serif'u003Eu003CFONT size=10u003Eu003CFONT size=2u003EPerforming regulatory administrative activities as neededu003C/FONTu003Eu003C/FONTu003Eu003C/FONTu003Eu003C/FONTu003Eu003CFONT face='arial, sans-serif'u003Eu003CFONT size=10u003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/FONTu003Eu003C/FONTu003Eu003C/LIu003Eu003CFONT color=black size=2 face=Arialu003Eu003C/ULu003Eu003CP style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/Pu003Eu003CTABLE class= FCK__ShowTableBorders cellSpacing=0 cellPadding=0 align=center vspace= hspace=\u003Eu003CTBODYu003Eu003CTRu003Eu003CTD vAlign=top align=leftu003Eu003CP style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003CFONT color=black face=Arialu003Eu003C/FONTu003Eu0026nbsp;u003C/Pu003Eu003C/TDu003Eu003C/TRu003Eu003C/TBODYu003Eu003C/TABLEu003Eu003CP style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/Pu003Eu003C/FONTu003Eu003C/TDu003Eu003C/TRu003Eu003C/TBODYu003Eu003C/TABLEu003Eu003C/DIVu003Eu003C/TDu003Eu003C/TRu003Eu003C/TBODYu003Eu003C/TABLEu003Eu003C/DIVu003Eu003C/FONTu003Eu003Cbu003EQualificationsu003C/bu003Eu003Cbr/u003Eu003Cbr/u003Eu003CDIVu003Eu003CTABLE class= FCK__ShowTableBorders cellSpacing=0 cellPadding=0 align=center vspace= hspace=\u003Eu003CTBODYu003Eu003CTRu003Eu003CTD vAlign=top align=leftu003Eu003CDIVu003Eu003CFONT size=2u003EEducation Minimum Requirement: u003C/FONTu003Eu003C/DIVu003Eu003CULu003Eu003CLIu003Eu003CFONT size=2u003EM.D. or PhD or other related doctoral degree in biological science, chemistry or related discipline. u0026nbsp;Masteru2019s degree with at least 3 years of relevant experience in pharmaceutical industry. Bacheloru2019s degree, with at least 6 years of relevant experience in the pharmaceutical industry.u0026nbsp; u003C/FONTu003Eu003C/LIu003Eu003C/ULu003Eu003CDIVu003Eu003CFONT size=2u003ERequired Experience and Skills: u003C/FONTu003Eu003C/DIVu003Eu003CULu003Eu003CLIu003Eu003CFONT size=2u003EExcellent communication skills (both oral and written)u003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT size=2u003EGood organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects u003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT size=2u003EFlexibility requiredu003C/FONTu003Eu003C/LIu003Eu003CLIu003Eu003CFONT size=2u003EStrong scientific and analytical skills with attention to detail.u003C/FONTu003Eu003C/LIu003Eu003C/ULu003Eu003CDIVu003Eu003CFONT size=2u003EPreferred Experience and Skills:u003C/FONTu003Eu003C/DIVu003Eu003CDIVu003Eu003CFONT size=2u003Eu003CFONT color=blacku003EPrior regulatory experience interacting with a major regulatory agency is highly preferred.u003C/FONTu003Eu0026nbsp; u003CFONT color=blacku003EExperience in drug development, particularly anti-infectives and/or vaccine products is highly preferred.u0026nbsp; u003C/FONTu003Eu003C/FONTu003Eu003C/DIVu003Eu003C/TDu003Eu003C/TRu003Eu003C/TBODYu003Eu003C/TABLEu003Eu003C/DIVu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003Eu003C/FONTu003Eu0026nbsp;u003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003EYour role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and weu2019re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, weu2019re inventing for life.u0026nbsp;u003C?xml:namespace prefix = o /u003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003Eu0026nbsp;u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003Eu003CFONT color=black size=2u003EIf you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request tou003C/FONTu003Eu003CA href=mailto:****\****u003C/Au003E. u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003Eu0026nbsp;u0026nbsp;u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003Eu003CBu003ESearch Firm Representatives Please Read Carefully:u0026nbsp;u003C/Bu003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003EMerck u0026amp; Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.u0026nbsp; Please, no phone calls or emails.u0026nbsp; All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.u0026nbsp; No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003Eu0026nbsp;u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003EFor more information about personal rights under Equal Employment Opportunity, visit:u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003Eu0026nbsp;u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003Eu0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u003CA href=****target=_blanku003Eu003CFONT color=blueu003EEEOC Posteru003C/FONTu003Eu003C/Au003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT size=2u003Eu0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u003CA href=****target=_blanku003Eu003CFONT color=blueu003EEEOC GINA Supplementu0026nbsp;u003C/FONTu003Eu003C/Au003Eu003C/FONTu003Eu003C/Pu003Eu003Cbr/u003Eu003Cbr/u003Eu003Cbu003EJob: u003C/bu003ERegulatory Affairs Liaisonu003Cbr/u003Eu003Cbu003EOther Locations: u003C/bu003ERahway, NJ, US u003Cbr/u003Eu003Cbu003EEmployee Status: u003C/bu003ERegularu003Cbr/u003Eu003Cbu003ETravel: u003C/bu003EYes, 5 % of the Timeu003Cbr/u003Eu003Cbu003ENumber of Openings: u003C/bu003E1u003Cbr/u003Eu003Cbu003EShift (if applicable): u003C/bu003E1stu003Cbr/u003Eu003Cbu003EHazardous Materials: u003C/bu003Eu003Cbr/u003Eu003Cbu003ECompany Trade Name: u003C/bu003EMerck,datePosted:2018-08-10,employmentType:FULL_TIME,industry:null,hiringOrganization:{@type:Organization,name:Merck USA},identifier:{@type:PropertyValue,name:Merck USA,value:REG003759-en_US},jobLocation:{@type:Place,address:{@type:PostalAddress,addressCountry:US,streetAddress:,addressLocality:Upper Gwynedd,addressRegion:PA,postalCode:19446}}}

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