- Parexel (Salem, OR)
- …related industry experience. - Direct experience in advertising and promotional regulatory review . - Familiarity with FDA regulations governing promotional ... - Track and manage promotional submissions and approvals in regulatory systems - Manage SOPs and electronic review... regulatory systems - Manage SOPs and electronic review systems. Qualifications - Education: Bachelor's degree in Life… more
- Teleflex (Morrisville, NC)
- …risk activities as well as other deliverables as related to projects. - Provide regulatory review for reporting activities required by EU MDR (ie post-market ... and submissions for complex projects across multiple business units and review issues related to regulatory documents, investigations, product development… more
- Post Holdings Inc. (St. Louis, MO)
- …+ Work with the company's R&D team, consultants, outside counsel, and regulatory authorities to review product formulas and obtain necessary approvals ... infrastructure + Oversee and direct the legal aspects of advertising regulatory authority related matters + Review , marketing materials, promotions,… more
- The Clorox Company (Durham, NC)
- …SB 312, CDER, Cosmetics Direct). **Documentation & Communication** + Prepare and review regulatory documentation including but not limited to ingredient ... team. #CloroxIsThePlace (https://www.linkedin.com/feed/hashtag/?keywords=cloroxistheplace&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7079847624048001024) **Your role at Clorox:** The Senior Regulatory Specialist will serve as a strategic regulatory… more
- Insmed Incorporated (NJ)
- …and consistency Lead document workflows throughout document lifecycles for regulatory documents, including creation, review , approval, revision, distribution, ... in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory ...Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs team to help us expand what's possible… more
- Insmed Incorporated (NJ)
- …product development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical functions ... for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global … more
- Wipfli LLP (Rockford, IL)
- …+ 5+ years of experience in credit underwriting, portfolio management, commercial lending, regulatory review , and/or loan review ; preferred candidates will ... season and limited hours during the team's off season. Responsibilities: + Review sample of commercial loans to ensure acceptable credit standards are maintained… more
- Wipfli LLP (Madison, WI)
- …+ 5+ years of experience in credit underwriting, portfolio management, commercial lending, regulatory review , and/or loan review ; preferred candidates will ... season and limited hours during the team's off season. Responsibilities: + Review sample of commercial loans to ensure acceptable credit standards are maintained… more
- Wipfli LLP (Wausau, WI)
- …+ 10+ years of experience with credit underwriting, portfolio management, commercial lending, regulatory review , or loan review ; experience with loan ... professional home, Wipfli offers a career-defining opportunity. Responsibilities The Loan Review Senior Consultant has the opportunity to work either remote, hybrid,… more
- Wipfli LLP (Chicago, IL)
- …+ 10+ years of experience with credit underwriting, portfolio management, commercial lending, regulatory review , or loan review ; experience with loan ... professional home, Wipfli offers a career-defining opportunity. Responsibilities The Loan Review Senior Consultant has the opportunity to work either remote, hybrid,… more
- GRAIL (Atlanta, GA)
- …regulatory strategy development, product validation, audits, promotional material review , on-market product support, and change control processes. This individual ... and laws applicable to GRAIL's business, providing guidance and recommendations. + Review and approve regulatory strategy documents, regulatory plans,… more
- SMBC (Jersey City, NJ)
- …in place to support effective controls. **Responsibility** + Lead and participate in the review of multiple regulatory filings such as FR Y-15, FFIEC 009, FFIEC ... **Role Description** The Director position is an integral member of the Regulatory Reporting Group which is a high-profile function that provides financial… more
- Parexel (Augusta, ME)
- …is the ideal role.** We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical ... shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront...FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc. or a related medical… more
- Parexel (Washington, DC)
- …of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative + Identify and resolve ... up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities + Review and sign off technical documents written by Parexel with… more
- ITG Brands (Greensboro, NC)
- …with regulatory agencies, industry groups, and external counsel. Draft, review , and negotiate regulatory -related agreements and documents. Educate and advise ... Senior Regulatory Counsel **Location** North Carolina **City** Greensboro **Role...+ We are seeking a seasoned and strategic Senior Regulatory Counsel to join our Legal and Regultaory team.… more
- Eisai, Inc (Philadelphia, PA)
- …Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May ... medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry… more
- Aequor (West Greenwich, RI)
- …materials, processes, and products comply with cGMP standards and other applicable regulatory requirements. Review and approve work orders and job plans ... bulk drug substance operations adhere to cGMP and other regulatory requirements. Key Responsibilities: Provide quality oversight for F&E,...within Maximo. Review logbooks (paper-based and electronic), particle-generating forms, pest control… more
- SMBC (Jersey City, NJ)
- … engagement and submissions** Prepare model documentation and technical writeups for regulatory review ; respond to examiner feedback and implement required ... that feed loss forecasting and capital planning processes, while ensuring regulatory compliance and strong model governance. **Role Objectives** + **Integration of… more
- Valero (Ardmore, OK)
- …Design, implement, and maintain programs in accordance with company standards and regulatory requirements. * Review effectiveness and modify on-site programs to ... as point of contact for local, state and federal government regulatory agencies, attorneys, consultants, trade organizations and general public on environmental… more
- CyrusOne (Dallas, TX)
- …noise and air studies, architects, civil, geotech, power and natural gas investigation, regulatory review and legal + Review due diligence documents ... executing new site acquisitions. Activities will include market analysis, site review , risk identification, land diligence, business development and assisting in… more
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