- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory /business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. ... while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role… more
- Formation Bio (New York, NY)
- …development through commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key role in scaling our biologics ... capabilities in partnership with technical, quality, and regulatory leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies… more
- Merck & Co. (Rahway, NJ)
- …aligned with our high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract ... findings with key stakeholdersServe as the global topic owner for regulatory inspections, audit & inspection CAPAs, and network observation sharingMaintain an… more
- Merck & Co. (Durham, NC)
- …on the customer. Author, review, and/or edit technical documents to support regulatory filings Author and approve validation procedures in accordance with our ... Company guidelines Support both internal and regulatory audits with coaching Subject Matter Experts (SMEs) and...matter expert in support of quality risk assessments and regulatory inspections. Partner with other area Validation leads to… more
- Tris Pharma (Monmouth Junction, NJ)
- …writing expertise and leadership in the preparation of clinical and regulatory documents. Collaborating closely with cross-functional teams to ensure accuracy and ... the incumbent contributes to development of research protocols and supporting regulatory submissions. She/he plays a crucial role in advancing organization's… more
- Formation Bio (New York, NY)
- …(IBs), clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory filings); and ... Partners with Formation Bio's tech team members to innovate and streamline regulatory writing processes through a combination of programmed automation solutions and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance. Essential Duties and Responsibilities: Program Leadership and Technical ... with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... matter expertise, a strong understanding of drug commercialization and the regulatory landscape.In this role, the successful candidate will be responsible toManage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those from Quality Events, Audits Findings and ... Regulatory Inspection (FDA/EMS/ PMDA etc.)Guide/advice RD, PV, MA business...Quality OversightPlay a key role in ensuring compliance with regulatory requirements while driving innovative quality solutions.Collaborate with Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced experience working on Phase I-IV ... therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills in continuous… more
- Formation Bio (New York, NY)
- …organizations (CDMOs) in close collaboration with Quality and Regulatory colleagues.Responsibilities: Provide analytical development technical leadership for ... resolution. Collaboration: Collaborate cross functionally with Manufacturing, Quality, and Regulatory colleagues to ensure seamless integration of analytical methods… more
- Twist BioScience (South San Francisco, CA)
- …of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our ... continuous improvement, technical excellence, robust software development practices, and regulatory compliance.Software Development & Implementation: Oversee the full Software… more
- Merck & Co. (Rahway, NJ)
- …compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations ... a strong network internally and across the external academic and regulatory community and build collaborations across internal company departments and key… more
- Genmab (NJ)
- …protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead ... Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with protocol… more
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