- Citigroup (New York, NY)
- The Rules, Regulations and QC Director will support the Head of RRP Regulatory Submissions in coordinating the maintenance of enhancements to the capability ... tools (eg, Wdesk, Microsoft Product Suite) to manage large scale regulatory submissions of 1000+ pages across 30+ stakeholder groups representing all of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the ... requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead… more
- Regeneron Pharmaceuticals (Troy, NY)
- …global markets. + Lead the preparation, coordination, and compilation of CMC regulatory submissions for non-US/EU markets in accordance with local regulations ... international health agencies in support of the CMC modules of regulatory submissions . + Keeps all stakeholders, including external partners, informed of… more
- Reynolds American (Winston Salem, NC)
- …Ensure appropriate documentation of product details for modern oral products in regulatory submissions to the FDA, including Premarket Tobacco Product ... SUBMISSIONS ** **SENIORITY LEVEL: Non-Management Level** **FUNCTION: Scientific & Regulatory Affairs** **LOCATION: Winston-Salem, NC** **ROLE POSITIONING AND OBJECTIVES**… more
- AbbVie (Chicago, IL)
- …other document management systems as applicable), data collation and tracking of regulatory submissions . + Participate in development of internal working ... of the Clinical Trial Strategy and Submission delivers clinical development regulatory strategies & operations for a designated portfolio of development compounds… more
- LSI Solutions (Victor, NY)
- … Specialists assigned to Domestic Regulatory Projects will 1) prepare regulatory submissions , including FDA Q- Submissions , 513(g) Submissions , ... Regulatory Projects will 3) work with distributors to prepare regulatory submissions required to market LSI's new or modified medical devices outside the… more
- Globus Medical, Inc. (Audubon, PA)
- …medical device development and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... PMA submissions a plus + Experience assessing regulatory impact of product/process changes + Experience reviewing labeling, promotional literature, etc. +… more
- Randstad US (Fort Worth, TX)
- …post-inspection follow-up information as requested. + Coordinate, prepare, or review regulatory submissions for domestic or international projects. + Interpret ... technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. +… more
- Fresenius Medical Center (Waltham, MA)
- …operational activities within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals ... Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or electronic format in accordance with… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …oversees departmental activities with regards to clinical trial conduct and regulatory submissions . **Responsibilities** + Actively leads development and ... of high quality, effective IND, CTA, NDA, NDS and MAA and related regulatory submissions and responses to regulatory agency requests: + develops and tracks… more
- Astellas Pharma (Westborough, MA)
- …global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. ... defined time schedules and meet established standards and SOPs. Reviews global regulatory submissions for consistency and quality across regions including… more
- Lilly (Indianapolis, IN)
- …submission or minimize risk. * Reviews and approves CMC documents for global regulatory submissions , including submissions for manufacturing changes, new ... Affairs CMC to be a part of the Lilly Global Regulatory Group to support global submissions and registrations. As the Project Leader, you will be expected to… more
- Kelly Services (Redondo Beach, CA)
- …Operations to Ensure Clinical Study Results and Reports are Suitable for Regulatory Submissions + Responsible for Adverse Event (Vigilance, MDR) Reporting ... as a Regulatory Representative to Marketing, Clinical, Research Teams, and Regulatory Agencies + Ensure Regulatory Submissions and Technical… more
- Teleflex (Maple Grove, MN)
- …projects. * Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance. * Interact and ... solutions that make a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies, submissions , and … more
- Caldera Medical (Westlake Village, CA)
- …approvals from worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project ... global regulatory strategies for all devices and preparing and submitting regulatory submissions in the both the US and OUS geographies. * Prepare Technical… more
- Integra LifeSciences (Harrisburg, PA)
- … strategies, and create and revise technical documentation for existing and new regulatory submissions . + Prepares regulatory strategies with minimal ... and response to questions with minimal supervision. + Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt… more
- Abbott (Alameda, CA)
- …life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or ... regulations or with EU and other international medical device regulations and submissions . + Familiar with relevant regulatory requirements for medical devices,… more
- AbbVie (North Chicago, IL)
- …enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications ... + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual… 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 ... acceptability of documentation for Class III and Class II medical device submissions and effectively communicate regulatory guidance. + Compile, prepare, review… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …that span outside of immediate job area. + Write, review, and file regulatory submissions to ensure MicroVention devices are commercially available in the ... regulatory agencies through oral and written communications regarding pre- submissions strategies, potential regulatory pathways, compliance test requirements,… more
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