- Merck & Co. (Rahway, NJ)
- …experts and regulatory colleagues in authoring of relevant regulatory submission analytical sections where needed.Required Qualifications:Education & ... Research and Development (ARD)-at our company's Research Laboratories is seeking a senior scientist to work onsite with extensive experience in validation &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...content templates and leads technical team in preparation of submission documents; authors regulatory documents where necessary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the construction of clinical development plans, clinical protocols, and in submission of certain regulatory documents. Responsibilities:Develop and implement a ... and Japan, for a tight alignment with the Global Project Team. In addition, he or she will interact...of clinical development plans, clinical protocols, and in the submission of certain regulatory documents from the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... supporting the overall CMC strategies within projects, and manage project teams. The project teams will be...and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group ... review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle is optimized across multiple programs. The CS group lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical… more
- 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
- J&J Family of Companies (Raritan, NJ)
- Senior Analyst, Immunology Regulatory Medical Writing - 2306143143W **Description** At Johnson & Johnson Innovative Medicine (IM), what matters most is helping ... Regulatory Medical Writing team are recruiting for a Senior Analyst, Immunology Regulatory Medical Writing to...colleagues from other departments. Able to lead program-level or submission writing teams with supervision. Able to lead process… more
- Sanofi Group (Bridgewater, NJ)
- …to cross-functional teams as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core ... submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation + Ensure that... timelines for clinical trial initiation + Ensure that regulatory messaging for regulatory submission … 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
