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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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On-Board Scientific is hiring a Nonclinical Regulatory Document and Scientific Writer based out of either New Brunswick, Lawrenceville or Summit, NJ! Qualifications: At minimum, a Bachelor’s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs. + years of Regulatory drug development experience Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
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Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
$207,763 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Innova Solutions is immediately hiring for a Nonclinical Regulatory Document and Scientific Writer. Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings.
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Accountable for collaboration with cross-functional teams, including research and development, legal, regulatory affairs, and business development, to ensure IP considerations are integrated into product development and commercialization strategies.
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The Senior Risk analyst supports Bank responses to audit, model risk management and regulatory examinations and for all Credit Risk Stress Testing Activities and coordinates these activities with the Senior Director - Risk Analytics, the as well as the heads of Model Development, Model Implementation, and Capital Planning.
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Partnering with cross functional teams internally including, but not limited to: Brand Marketing, Customer Teams, Customer Strategy, Shopper Insights, Visual Merchandising, Category Management, Creative Solutions, Digital Activation, Media Services, Legal & Regulatory, and others, as necessary, to align objectives across all key stakeholders to enable the successful execution of shopper marketing programs.
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This role requires a strong leader with a deep understanding of commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance. As a Quality and Compliance Team Lead, you will serve as a liaison to key clients, where your leadership and expertise will contribute to the continuous improvement of our drug safety processes, regulatory and contract compliance, and overall patient safety.
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Prepare/review technical documents including development/tech transfer reports and CMC regulatory submissions - Participate on cross-functional teams to progress both early and late stage drug candidates.
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Proven technical capabilities and relevant project experience with management and oversight of cross-disciplinary technical and regulatory specialist teams of other professionals. Coordinate, manage, and direct development of project permitting applications, environmental resource reports, technical study reports and regulatory documents.
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Collaborate as appropriate with Everest’s Chief Compliance Officer in monitoring and updating compliance policies and procedures governing disclosure requirements worldwide; assist with the design of related compliance training; develop strategies for efficient, effective compliance with legislative and regulatory requirements; and participate in internal investigations as needed.
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This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures.
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regulatory job Company: Bluepipes in Bernards, NJ
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