- Genmab (NJ)
- …and approve any amendments, corrections, and updates of data packagesSupport regulatory submission/filing activitiesExperience:Master's or PhD in a statistical ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Merck & Co. (Rahway, NJ)
- …Skills:Required:Global Regulatory experience required across various modality types.M.D. or PhD with >20 years relevant experience preferably with >15 years in ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the...contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our… 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
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory… more
- Genmab (NJ)
- …the CSR Attend operational and steering committee meetings, as applicableSupport regulatory submission/filing activitiesRequirements:MS / PhD or equivalent in a ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Merck & Co. (South San Francisco, CA)
- …stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development, ... stay up to date regarding industry trends and diagnostic regulatory requirements. Essential Job Requirements:Develop end-to-end diagnostic strategy in collaboration… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (North Wales, PA)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … 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. (South San Francisco, CA)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide clinical pharmacology… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... clinical development, including study design, initiation, execution,- monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior-level and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …utilize prior industry experience to optimize resource allocation, ensure regulatory compliance, and uphold rigorous scientific standards. Understanding best ... identify Federal Government research opportunities to develop additional revenue streams. Regulatory Oversight: Uphold the highest standards of quality and compliance… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company Research… 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
- Merck & Co. (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Lead the Device… more
- Formation Bio (New York, NY)
- …to integrate imaging AI solutions into trial protocols and workflows Partner with regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for ... to executive leadership and external partners About YouRequired Qualifications PhD in Computer Science, Biomedical Engineering, Medical Physics, or related… more
- Merck & Co. (Rahway, NJ)
- …from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact ... ensure they are developed and manufactured in accordance with regulatory , company, and customer requirements.- -Principal ResponsibilitiesLead/contribute to device… more
Related Job Searches:
PhD,
PhD Regulatory Analysis,
PhD Regulatory Science,
Regulatory,
Regulatory Affairs PhD,
Research Development PhD Regulatory