- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Clinical Trial Application (CTA) submission deliverables + Manage CTA regulatory submission /document transfers between Regeneron and CROs. This can include ... Research Organizations (CROs), as well as corporate and collaborative partners, Regulatory Liaisons, vendor management and other cross-functional team members. **In… more
- Publicis Groupe (New York, NY)
- …with the stability and experience of a global leader. **Job Description** The Senior Manager, Regulatory Promotional Operations, is a subject matter expert ... to ensure a seamless MLR review process from start to finish. The Senior Manager provides expert guidance on submission timelines and resource requirements,… more
- Publicis Groupe (New York, NY)
- …of a global leader. **Job Description** The Senior Associate, Regulatory Promotional Operations is a project -level lead responsible for independently ... MLR process, facilitating effective communication among cross-functional team members regarding project statuses, advising on submission timelines, and following… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and responses to regulatory agency requests: + develops and tracks submission timelines with RA Project Operations + actively participates in product ... evidence, and creating hope for all facing illness. The Senior Director, Regulatory Affairs - Clinical (Neuroderm),...and vendors); participates as a key member of Global Regulatory Project Teams; and represents Regulatory… more
- Citigroup (New York, NY)
- The Capital Markets Regulatory Engagement Senior Officer-SVP is a strategic professional who closely follows latest trends in own field and adapts them for ... and coordinate with appropriate internal stakeholders, + Aid in the preparation of regulatory responses to ensure timely and accurate submission , Provide review… more
- Organon & Co. (Jersey City, NJ)
- …not limited to: **Responsibilities** + Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying ... **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry, Manufacturing and Controls, the Senior Scientist is responsible for… more
- Publicis Groupe (New York, NY)
- …the stability and experience of a global leader. **Job Description** The Senior Associate, Regulatory Promotional Operations must follow the protocol established ... by our pharmaceutical company clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to the… more
- Publicis Groupe (New York, NY)
- …| Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Senior Associate, Regulatory Review must follow the ... by our pharmaceutical company clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to the… more
- Publicis Groupe (New York, NY)
- …the submission process and ensuring compliance with client-specific and regulatory requirements. **DUTIES & RESPONSIBILITIES:** + Act as a brand lead, overseeing ... regulatory requirements. + Independently prepare and deliver high-quality submission packages through taking screenshots, organizing materials to output a… more
- Publicis Groupe (New York, NY)
- …and client teams to develop, document, and enhance the Medical, Legal, Regulatory (MLR) submission and review processes. They provide expert advice ... portfolio of multifaceted brands, ensuring alignment with client expectations and regulatory requirements. Manage the overall submission strategy and execution.… more
- Publicis Groupe (New York, NY)
- …device clients for promotional materials. This includes managing components of a submission package based on project type, experience working in Veeva ... all-around nice person, let's chat. **Job Description** The Manager, Regulatory Review is responsible for ensuring regulatory ...as a point of contact for internal Account and Project Management teams to answer submission questions… more
- Citigroup (New York, NY)
- …and subject-matter experts (SMEs) to prepare RRP submissions aligned with senior management and regulatory requirements and expectations. **Responsibilities** + ... to the Head of Resolution & Recovery Planning (RRP), the Head of RRP Regulatory Submissions is responsible for leading and providing oversight and support of the… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …with a cross-functional team supporting product development, but also to interact with senior managers in the company on regulatory strategies for product ... regulatory commitments/requirements. In addition the position assists corporate senior management in understanding Regulatory strategies/processes while… more
- Pfizer (New York, NY)
- …into region and possibly site-specific deliverables. + Responsible for regional regulatory project /product governance, and global governance as appropriate. + ... + Represent Global Regulatory Sciences (GRS) International Regulatory Sciences on senior leadership committees and...time, cost and quality in each region to meet submission and approval targets for all submission … more
- Citigroup (New York, NY)
- … regulatory interactions, including meetings and information requests, to strengthen regulatory relations; + Produce thematic summaries to Senior Management ... in regulatory interactions. The role will support the broader Risk Regulatory Engagement team ensure Senior Management remain informed of regulatory… more
- Citigroup (New York, NY)
- …and subject-matter experts (SMEs) to prepare RRP submissions aligned with senior management and regulatory requirements and expectations. **Responsibilities** + ... and QC Director will support the Head of RRP Regulatory Submissions in coordinating the maintenance of enhancements to...Finance and Legal to gather necessary inputs for RRP submission + Perform review and challenge and quality control… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …requirements against the governance approved developmentplan and resources. Represent the project at senior management and governance stage-gate approval ... required for senior management on a global basis. + Support regulatory safety reporting for clinical programs: SAE assessment, queries and follow-up, annual… more
- Citigroup (Queens, NY)
- …changes for JTD and CVA are well understood, implemented and tested for regulatory notification and submission . This will include developing insights estimating ... governance, data and non-data controls, processes, system implementation and regulatory reporting. + Develop senior management-ready materials, particularly… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Science, review and improve the clinical trials protocols and documents intended for regulatory submission . + Complies with all regulatory , compliance, ... required for senior management on a global basis. + Support regulatory safety reporting for clinical programs: SAE assessment, queries and follow-up, annual… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …global regulatory filings. **How you'll spend your day** The Senior Director: + Will foster relationships with opinion leaders in assigned ... Senior Director Clinical Development - Respiratory Date: Aug...Oversees the preparation of documents for IND/NDA and other regulatory documents + May lead an NDA submission… more