Regulatory Affairs Manager

ForDoz Pharma Corp., based in East Windsor, New Jersey, is a fully integrated pharmaceutical company specializing in the development and manufacturing of advanced sterile injectable drug products. Rooted in a commitment to quality excellence, ForDoz continues to expand the expertise and production capacity for both conventional and complex sterile drug formulations in the U.S.Role DescriptionThis is a full-time, on-site role for a Regulatory Affairs Manager, located in East Windsor, NJ. The Regulatory Affairs Manager will be responsible for overseeing regulatory submissions, ensuring compliance with regulatory requirements, and maintaining quality systems. ResponsibilitiesThe Senior Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirementsServe as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organizationApprove, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirementsResponsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed productsAssist with developing and evaluating regulatory strategyKeep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on ForDoz productsAuthor and review departmental SOPs, as well as other SOPs that may impact Regulatory AffairsPerforms other special projects and duties as requestedQualificationsBachelor’s Degree in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development required; or Master’s Degree in life sciences required with 5+ years of relevant regulatory compliance experience in pharmaceutical drug development requiredKnowledge and experience with organizing responses to Regulatory Authority requests requiredKnowledge of FDA, ICH and other guidance documents and requirementsKnowledge of organizing responses to Regulatory Authority requestsStrong knowledge of Health Authority regulatory requirements/guidelinesStrong project management and computer skills (including Microsoft office)Strong document management experience (hard and e-copy)Ability to work with firm deadlines and adapt quickly to changing requirements and prioritiesStrong organizational skills, written/oral communication skills and attention to detailAbility to manage conflicting priorities and respond in a timely, effective mannerKey AttributesDetail-oriented with strong problem-solving skillsProactive, self-motivated, and results-drivenComfortable navigating ambiguity and changing prioritiesStrong sense of ownership and accountabilityPay: $135,000 - 150,000 per yearBenefits:401(k)Dental insuranceHealth insurancePaid time offVision insuranceForDoz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics