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Demonstrate expertise in BSA/AML and OFAC including: BSA/AML and OFAC laws and regulations as well having a some understanding and experience of how to apply requirements in financial service environmentCreative problem-solving abilities and ability to interpret information and regulatory requirements in order to advise clients on compliance issues by implementing sound solutions.
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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The Safety Manager - Regulatory Compliance will lead a cross functional team that handles critical regulatory compliance programs throughout AmeriGas. The compliance responsibilities include Process Safety Management (PSM), Risk Management Program (RMP), Office of Pipeline Safety (OPS), and Department of Homeland Security (DHS) related activities.
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Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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Represent Global CMC Regulatory advising teams on global regulations and guidelines and providing strategic direction to cross-functional matrix project teams on medical device and drug/device combination product related topics.
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The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures.
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Counsel and advise the HPP business in areas of product safety (including TSCA, FIFRA, FDA, REACH, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of HPP products.
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Provides key insight to identify IT solutions to enhance Regulatory Operations systems (i.e., Project planning tools, Veeva RIM) The Associate Regulatory Operations Director is responsible for overseeing submission activity for the company's submission portfolio, with first line accountability for managing the submission forecast and ensuring proper staffing for upcoming submissions.
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Develop a regulatory management program to ensure consistent implementation of PSM, RMP, OPS, DOT and DHS initiatives across AmeriGas and to monitor compliance. Communicate regulatory updates and risks associated with applicable agency regulations to AmeriGas Leadership Team.
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Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC) and team members to enhance these relationships.
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O Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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When needed, participate in corporate evaluation and provide CMC Regulatory support/advice to in-licensing and divestment projects. Ensure Global CMC Regulatory have processes and procedures in place to stay in compliance with those regulations.
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Experienced Associate General Counsel Opportunity in Bryn Mawr, PA
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Liaises with Worldwide Safety & Regulatory (WSR) Country Offices, Global Labeling Management (GLM), the geographically distributed artwork centers within Global Supply (GS). Title: Safety & Regulatory QC.
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As a Director in our Regulatory Implementation role embedded in one of our Software divisions, you belong to the functional team whose work encompasses product delivery, project management, client-specific implementation, and custom handling of the customer experience for strategic accounts.
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Title: regulatory Company: Impact Legal Resources in King Of Prussia, PA
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