- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory ... FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions .Support FDA meeting preparation including preparation of… more
- Eisai, Inc (Exton, PA)
- …strategies throughout the lifecycle of pharmaceuticals. Coordinates the preparation of CMC regulatory submissions that meet global regulatory requirements, ... to improve efficiency. Essential Functions 1. Development Projects Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides guidance to ROI staff as needed during assembly of regulatory submissions .Advertising and PromotionGain understanding of how prescription drug ... required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted ... flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics. Support… more
- Aequor (Tallahassee, FL)
- …wording for case related data exchange Monitoring compliance in regard to regulatory submissions and/or contractual wording for data exchange Assign tasks ... to MAX Shift/Schedules- Flex, normal dayshift hours Title (Role) Case Management - Manager Organization Global Patient Safety Intake Call Notes with HM: What are the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Centers of Excellence, Corporate Communications, etc.) Also interacts with Sales, Medical, Regulatory , and Legal. The Manager leads, manages, and directs a ... approval, distribution and lifecycle management of promotional marketing materials. The Manager will oversee the process across designated portions of the portfolio… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …time and within budget to support drug development processes and global submissions . This position also partners with internal and external stakeholders to optimize ... this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies… more
- 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
- 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
- Bank of America (Charlotte, NC)
- …monitor the Company's RRP capabilities and act as a review and challenge function for regulatory submissions . The Stress Testing Manager will lead the Legal ... Stress Testing Manager - RRP Charlotte, North Carolina **Job Description:**...Line Units and Control Functions to prepare content for regulatory submissions + Lead preparation of materials… more
- Takeda Pharmaceuticals (Lexington, MA)
- …my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management in ... requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead… more
- AbbVie (Chicago, IL)
- …other document management systems as applicable), data collation and tracking of regulatory submissions . + Participate in development of internal working ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager of the Clinical Trial Strategy and Submission delivers clinical development… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …better understanding. + Processes reportability decisions and is able to complete MDR submissions . + Assist in the preparation of regulatory body additional ... would consider. * Olympus is looking for Global MDR Submissions Analyst III. Hiring Location: US **Job Description** As...The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …geographic locations you would consider. * Olympus is looking for Global MDR Submissions Analyst II. Hiring Location: US **Job Description** Global MDR Analyst II is ... and Customers directly; Performs routine assignments with minimal direction from manager ; requires general instruction for new or special assignments from … more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works ... enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications… more
- Abbott (St. Paul, MN)
- …robust global regulatory strategies, working with cross-functional teams as the regulatory SME, compiling regulatory submissions , and ensuring data is ... heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Manager ** to join our team...documentation for Class III and Class II medical device submissions and effectively communicate regulatory guidance. +… more
- Bausch Health (San Francisco, CA)
- …proven and effective aesthetic care options to consumers and physicians alike. The Manager , Regulatory Affairs provides direct support to Solta operations for ... Role:** + Develops regulatory strategies for new product launch & authors submissions for major markets (US, Canada, EU) as assigned. + Evaluates product changes… more
- Abbott (Alameda, CA)
- …as industry trends and trains staff regarding changing regulations that affect regulatory submissions . Maintains knowledge of current and pending regulations ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - Digital Health Technology**...project teams. + Sets strategy and directs preparation of submissions for products to regulatory agencies, to… more
- Philips (Chicago, IL)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' ... the current portfolio in connection with future innovations. + Building FDA regulatory submissions strategy for the products portfolio, providing related… more
- BeiGene (Emeryville, CA)
- …life cycle of a drug product. + Manage/prepare CMC document packages for regulatory submissions in support of development programs. This includes initial ... **General Description:** + The Senior Manager , Regulatory Affairs CMC, is responsible...which present CMC information. + Develop and implement effective regulatory CMC strategies for global submissions knowing… more
