Theradex Oncology
Regulatory Affairs Manager/Sr Manager (GCP)
Theradex Oncology, Princeton, New Jersey, us, 08543
Regulatory Affairs Manager/Sr Manager (GCP)
Job Locations:
US-NJ-Princeton | USID:
2024-1336Category:
RegulatoryType:
Full TimeWho We Are
Celebrating 40+ years!Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.What You'll Do
Regulatory Affairs Manager/Sr Manager - CGP - Oncology Trials - Remote USThis strategic role will report to the President. The successful candidate needs a thorough understanding of drug development process as well as hands-on experience managing the creation, review and finalization of regulatory submissions.We are seeking an experienced, forward thinking hands-on leader. Project Management experience is essential. Regulatory experience in oncology or immunology is highly preferred. This is a great opportunity if you are a highly motivated team player, have the ability to plan proactively, work independently and have a strategic results oriented mindset.In this role you will interact with all levels of company personnel based on role requirements. You'll serve as the primary point of contact for all regulatory responsibilities associated with assigned projects and represent regulatory function at cross function discussions. You'll liaise with vendor representatives, candidates, auditors and external agencies as required.The primary responsibilities of this position include, but are not limited to, the following:Provide strategic regulatory input to all regulatory projectsManagement, preparation, assembly of the Master Core Dossier and submissions of US/European:Clinical Trial Authorization Applications (CTAA) and amendmentsCountry-level Informed Consent and other patient facing documentationTracks, reports and files CTAA and amendment submissions/approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systemsProactively provides strategic direction to the client on regulatory specific issues and provides associated mitigation as requiredParticipates in the quality control (QC) steps involved for all the aboveServes as key regulatory liaison on behalf of Theradex. Liaison with other departments within Theradex, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug DistributionMaintains metrics on a monthly basis of all regulatory submissions made by TheradexStrategic cross-functional interaction with a variety of departments to provide regulatory solutions to problems including the management of timelines to complete regulatory submissions on timeResponsible for providing assistance to perform effectively the planning, critical reviews and scientific writing of a number of regulatory activities such as IMPDs, DSURs, study protocols, IBs and patient information sheets in order to successfully obtain the regulatory approvalValidates and provides input into our clients' regulatory development strategies, support our clients in preparing for and obtaining scientific advice from EU Competent Authorities and the EMA and prepare Orphan Drug Applications where requiredSupports clients in preparing for advice meetings with national RAs or the European Medicines AgencyMaintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trialsSupports Head of Department in business development activities including the preparation of client proposals and bid defense meetingsProvides regulatory training to other members of the team as requiredWhat You Need
Level of Education and ExperienceBachelor's degree required preferably in a life science field or equivalentAt least 5 years of industry experience in a regulatory role, preferably in oncology or immunologyPrior experience in a CRO/pharmaceutical environment requiredProject Management Experience is essentialAdditional RequirementsAbility to travel if needed based on project requirements or to travel to our Princeton, NJ headquarters for sponsor/audits etc.Skills and CompetenciesDetailed Knowledge of ICH-GCP and local regulatory agency and ethics Committee regulations and requirementsThe ability to stay informed about new guidelines and regulations as they are issued by regulatory authoritiesDemonstrates ability to build and maintain effective relationships with others, establishing collaborative partnerships, trust and shared purposeAbility to anticipate problems relating to projects and to develop and implement solutionsExcellent interpersonal skillsFluent knowledge of written and verbal EnglishHighly organized and result-orientedAbility to work independently as well as in a team environmentProficient knowledge of Microsoft Office packages including but not limited to Word and ExcelWhat We OfferWe offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.Theradex is an Equal Opportunity Employer.Theradex is not utilizing agencies for this role. Unsolicited resumes will not be accepted.
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Job Locations:
US-NJ-Princeton | USID:
2024-1336Category:
RegulatoryType:
Full TimeWho We Are
Celebrating 40+ years!Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.What You'll Do
Regulatory Affairs Manager/Sr Manager - CGP - Oncology Trials - Remote USThis strategic role will report to the President. The successful candidate needs a thorough understanding of drug development process as well as hands-on experience managing the creation, review and finalization of regulatory submissions.We are seeking an experienced, forward thinking hands-on leader. Project Management experience is essential. Regulatory experience in oncology or immunology is highly preferred. This is a great opportunity if you are a highly motivated team player, have the ability to plan proactively, work independently and have a strategic results oriented mindset.In this role you will interact with all levels of company personnel based on role requirements. You'll serve as the primary point of contact for all regulatory responsibilities associated with assigned projects and represent regulatory function at cross function discussions. You'll liaise with vendor representatives, candidates, auditors and external agencies as required.The primary responsibilities of this position include, but are not limited to, the following:Provide strategic regulatory input to all regulatory projectsManagement, preparation, assembly of the Master Core Dossier and submissions of US/European:Clinical Trial Authorization Applications (CTAA) and amendmentsCountry-level Informed Consent and other patient facing documentationTracks, reports and files CTAA and amendment submissions/approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systemsProactively provides strategic direction to the client on regulatory specific issues and provides associated mitigation as requiredParticipates in the quality control (QC) steps involved for all the aboveServes as key regulatory liaison on behalf of Theradex. Liaison with other departments within Theradex, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug DistributionMaintains metrics on a monthly basis of all regulatory submissions made by TheradexStrategic cross-functional interaction with a variety of departments to provide regulatory solutions to problems including the management of timelines to complete regulatory submissions on timeResponsible for providing assistance to perform effectively the planning, critical reviews and scientific writing of a number of regulatory activities such as IMPDs, DSURs, study protocols, IBs and patient information sheets in order to successfully obtain the regulatory approvalValidates and provides input into our clients' regulatory development strategies, support our clients in preparing for and obtaining scientific advice from EU Competent Authorities and the EMA and prepare Orphan Drug Applications where requiredSupports clients in preparing for advice meetings with national RAs or the European Medicines AgencyMaintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trialsSupports Head of Department in business development activities including the preparation of client proposals and bid defense meetingsProvides regulatory training to other members of the team as requiredWhat You Need
Level of Education and ExperienceBachelor's degree required preferably in a life science field or equivalentAt least 5 years of industry experience in a regulatory role, preferably in oncology or immunologyPrior experience in a CRO/pharmaceutical environment requiredProject Management Experience is essentialAdditional RequirementsAbility to travel if needed based on project requirements or to travel to our Princeton, NJ headquarters for sponsor/audits etc.Skills and CompetenciesDetailed Knowledge of ICH-GCP and local regulatory agency and ethics Committee regulations and requirementsThe ability to stay informed about new guidelines and regulations as they are issued by regulatory authoritiesDemonstrates ability to build and maintain effective relationships with others, establishing collaborative partnerships, trust and shared purposeAbility to anticipate problems relating to projects and to develop and implement solutionsExcellent interpersonal skillsFluent knowledge of written and verbal EnglishHighly organized and result-orientedAbility to work independently as well as in a team environmentProficient knowledge of Microsoft Office packages including but not limited to Word and ExcelWhat We OfferWe offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.Theradex is an Equal Opportunity Employer.Theradex is not utilizing agencies for this role. Unsolicited resumes will not be accepted.
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