- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- BioSpace (Tarrytown, NY)
- …the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) ... Job Details The Senior Manager position within the Regulatory Affairs...to advertising and promotion matters, including request for advisory submissions . Responsible for compliance with promotional material submissions… more
- Katalyst HealthCares and Life Sciences (Trenton, NJ)
- Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing ... packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and… more
- BitGo (Sioux Falls, SD)
- …regulatory interviews and presentations Gather and organize required data for regulatory submissions Submit timely information and documentation to ... For more information, visit www.bitgo.com. We are seeking an experienced Regulatory Compliance Manager to join our team and oversee critical compliance functions… more
- Capstan (Santa Cruz, CA)
- …to join a well-funded, early-stage start-up positioned to revolutionize structural heart care. The Manager of Regulatory Affairs will help build and execute the ... Reports to: Head of Regulatory Affairs (SVP, RA) Workplace type: Hybrid Description:...effective internal and external communication and to manage accurate/complete submissions . Requirements: BS Degree in a scientific discipline; MS… more
- Globus Medical (Audubon, PA)
- …in medical device development and registration of products Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for...PMA submissions a plus Experience assessing regulatory impact… more
- Envista (Brea, CA)
- …and literature. Prepares monthly reports on status of current issues to the Manager of Regulatory Affairs. Assists with Customs requests. Responsible for global ... submissions (as required). Tracks submissions and maintains electronic and paper regulatory ... Affairs Management. Any duties or projects assigned by Manager . REQUIREMENTS: Bachelor's Degree (BA/BS) from four-year college/university 2+… more
- Intuitive (Sunnyvale, CA)
- …communication skills, proven ability to translate technical documentation into effective regulatory submissions . Good interpersonal skills and able to work ... experience is required. Minimum 4 years of working experience supporting international submissions preferred; Previous China regulatory affairs experience is a… more
- U-Haul (Phoenix, AZ)
- …systems. Growth Path: This role provides an opportunity to grow into a Regulatory Compliance Manager or Senior Compliance Analyst with additional experience and ... Work with Actuarial and Finance teams to ensure accurate filing submissions . Monitor regulatory agency websites for any changes affecting Med Supp rates. Monthly… more
- Katalyst HealthCares and Life Sciences (Pleasanton, CA)
- …assists in creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change ... development teams and commercial support with guidance. Participates in preparing regulatory strategies. Reviews submissions , regulatory commitments,… more
- Loyola University Chicago (Chicago, IL)
- …Staff on regulatory process including CITI training, Study start-up, IRB submissions , maintaining a Study, and ensuring all essential documents are correct to ... Position Details Position Details Job Title SR. REGULATORY COORDINATOR Position Number 8150786 Job Category University Staff Job Type Full-Time FLSA Status Exempt… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Genmab (NJ)
- …Health Authority briefing documents and responses, and clinical modules of regulatory submissions (eg, NDA, BLA, MAA).Drive collaboration with cross-functional ... are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our...the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... programming efforts of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical… more
- Walker Digital Table Systems LLC (Las Vegas, NV)
- …and test reports. *Develop standardized processes and documentation to support efficient regulatory submissions . *Monitor regulatory updates specific to ... role ensures that all gaming products meet jurisdictional technical standards, regulatory guidelines, and submission requirements. The Compliance Manager will… more
- Elliquence (Baldwin, NY)
- …(eg, design history files, risk management files, and verification/validation protocols) for regulatory submissions . Work closely with regulatory affairs to ... We are seeking an experienced Product Development Manager with a strong background in engineering and...prepare submissions for FDA 510(k) or other regulatory approvals for medical devices. Innovation and Technical Expertise:… more
- Cresilon, Inc. (Brooklyn, NY)
- …They are responsible for leading the creation of documentation required for regulatory submissions , developing strategies for grants and publications, and ... Learn more about the company at www.cresilon.com. The R&D Formulation Manager /Principal Scientist will lead the design, development, and implementation of novel… more
- Alkermes (Waltham, MA)
- …hands-on writing, this role provides strategic input into clinical development and regulatory submissions , leads process improvements within Medical Writing, and ... Job Description The Senior Manager , Medical Writing, is a key member of...investigator brochures (IBs), and at times clinical modules of regulatory submissions . Collaborate cross-functionally with Biostatistics, Clinical… more
- Reworld (Conshohocken, PA)
- …you. Apply today! About the role Sign on bonus eligible! Reporting to the Facility Manager and the Area or Regional Safety Manager , the Safety Program Manager ... As the SPM, you will be responsible for overseeing regulatory compliance, training and implementation of Reworld's safety policies,...the facility safety and health activities. The Safety Program Manager will also be called upon to contribute to… more
- Boston Scientific (Marlborough, MA)
- …vendor contracts and ensuring expenditures are within budgetary guidelines. Facilitates regulatory submissions and communications by communicating with ... progressing - whatever your ambitions. About the role: The Senior Clinical Trial Manager (CTM) will be responsible for the design, planning, execution and leadership… more
