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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.
$107,659 - $207,763 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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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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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
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Prepare/review technical documents including development/tech transfer reports and CMC regulatory submissions. Downstream process development, process optimization, process characterization, and tech transfer.
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Must have completed most of the requirements towards earning the ABA Certified Regulatory Compliance Manager (CRCM) certification). Participate in regulatory compliance examinations performed by the OCC and CFPB. Documents results and presents to management.
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The Senior Statistical Analyst interfaces with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.) + Fundamental understanding of the drug development process, including experience with regulatory filings.
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Monitor and stay abreast of relevant global, federal and state laws and regulations affecting the cloud services industry and ensure company compliance with applicable regulatory frameworks, including with respect to privacy and data protection, artificial intelligence, export controls, and sanctions.
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Work with R&D scientists, regulatory, commercial, and management teams to provide quick and accurate IP and other legal advice on all aspects of the Hatch-Waxman Act, including the timing of product approvals and launches.
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Understanding of PhRMA, OIG, and ACCME guidelines and policies as well as other regulatory, legal, ethics/compliance guidelines/regulations. Ensure 100% compliance with OGE SOPs, regulatory, industry, and OIG guidelines.
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The Vendor Risk Management Specialist is responsible for supporting Vendor Management's First Line of Defense and Contract Owners / Relationship Managers during vendor due diligence and ongoing monitoring to ensure policy requirements are complete and meet company standards and applicable regulatory requirements.
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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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O Enforces safety procedures concerning service, fleet use, and Personal Protective Equipment in accordance with all corporate and regulatory requirements (e.g. HazMat, DOT, FMCSA, OSHA). Job DescriptionJob DescriptionDIXON ENERGY Propane Manager - Rockaway, NJDixon Energy has a proud legacy of more than 100 years serving the fine communities of Morris, Union, Somerset and southern Sussex Counties.
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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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Qualifications & Experience: B.S. in Chemical/Biochemical Engineering, Biotechnology, Biochemistry, or related biologics fields with 0 - 2 years of industry experience is required Prior hands-on experience with downstream process development, including preparative chromatography, ultrafiltration/diafiltration, viral inactivation, viral filtration and high throughput robotic platforms is desired.
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regulatory job in Morris Plains, NJ
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