- Actalent (Cambridge, MA)
- Job Title: Regulatory Submissions Specialist Job Description We are seeking a highly skilled Regulatory Submissions Specialist to manage ... leads to create content plans and submission timelines for regulatory submissions . + Organize and facilitate kick-off...+ Serve as the point of contact and alliance manager for selected regulatory vendors, ensuring timely… more
- US Bank (Minneapolis, MN)
- …bank. This will include creating and maintaining CCAR and third-party data submissions to both commercial and regulatory stakeholders, automating and simplifying ... from Day One. **Job Description** We are seeking an experienced (3-5+ years) Submissions Reporting Analyst to join our CCAR and Third-Party Submissions team.… more
- Spectrum Plastics Master (Tucson, AZ)
- … guidance throughout the product development cycle and coordinating team inputs for regulatory submissions . + Communicate with regulatory agencies regarding ... or clinical study compliance issues. + Determine the types of regulatory submissions or internal documentation that are required in situations such as… more
- United Therapeutics (Silver Spring, MD)
- …strategy, providing regulatory advice and oversight to project teams and supporting regulatory submissions and department activities. This role serves as a ... and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior ...documentation needs and timelines, and supporting preparing and executing regulatory submissions . This is a hybrid position… more
- Dana-Farber Cancer Institute (Boston, MA)
- …established timelines. The AROM is directly responsible for closely managing all regulatory submissions reaching the activation phase to ensure both Clinical ... The Assistant Regulatory Operations Manager (AROM) is a...manage the delegation of quality assurance checks for iRIS submissions and assist with Regulatory -Coordinator onboarding, training,… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. As Manager Regulatory Lead you will be accountable for recommending and ... subteam (GRT) and, cross-functional subteams and working group to execute regulatory submissions . Assists in the creation and submission of high quality,… 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 ... heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Manager ** to join our team...documentation for Class III and Class II medical device submissions and effectively communicate regulatory guidance. +… more
- Kelly Services (Seattle, WA)
- … authorities worldwide. You will assist in the development and execution of CMC regulatory strategies, regulatory submissions (IND, BLA, NDA) in the area ... Kelly(R) Science & Clinical is seeking a Manager , CMC Regulatory Affairs for a... Regulatory Affairs (CMC) is responsible for providing regulatory support and guidance on CMC -related submissions… more
- Medtronic (North Haven, CT)
- …Program Manager will lead the strategic planning and execution of regulatory submissions and compliance initiatives within the Advanced Surgical Technologies ... cross-functional teams, including R&D, Quality, Clinical, and Marketing, to drive regulatory submissions and maintain compliance throughout the product… more
- Lundbeck (Deerfield, IL)
- Senior Manager Regulatory Strategy - Remote Opportunity Requisition ID: 5804 Location: Deerfield, IL, US Do you want to join a team where the mission is ... States. Preferably East Coast or Midwest.** **SUMMARY:** The Senior Manager , Regulatory Strategy (US RA): supports the... regulatory review of product documentation intended for regulatory submissions for accuracy and compliance with… more
- Takeda Pharmaceuticals (Boston, MA)
- …under oversight of manager . + Accountable for ensuring all other regulatory submissions within the non-US "Americas" territories are submitted on schedule ... therapies to patients worldwide. Join Takeda as a Senior Manager , Global Regulatory Lead, GI & Inflammation...Preferred experience in reviewing, authoring, or managing components of regulatory submissions . + Working knowledge of drug… more
- Abbott (Alameda, CA)
- …as industry trends and trains staff regarding changing regulations that affect regulatory submissions . Maintains knowledge of current and pending regulations ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - Digital Health Technology**...project teams. + Sets strategy and directs preparation of submissions for products to regulatory agencies, to… more
- Abbott (Santa Clara, CA)
- …results for millions of people. **What You'll Work On** We are recruiting for a SENIOR MANAGER REGULATORY AFFAIRS to join the Regulatory team at the Santa ... product release process. + Review protocols and reports to support regulatory submissions . + Support all Company initiatives as identified by management and… more
- Stryker (Portage, MI)
- …and procedures are in place for appropriate internal review and approval of regulatory submissions + Represent regulatory processes during internal and ... More information is available at www.stryker.com We are currently seeking a ** Manager , Regulatory Affairs** to join our **Instruments** **Division** . This… more
- System One (Florham Park, NJ)
- …This role involves actively contributing to the development and execution of regulatory strategies, regulatory submissions , and collaboration with regional ... Senior Manager , Regulatory Affairs (BRANDED PRODUCTS) Must...to collaborate effectively with cross-functional teams. + Knowledge of regulatory submissions and documentation processes. + Awareness… more
- BeiGene (Emeryville, CA)
- …+ Develop and implement strategies for the earliest possible approvals/clearance of regulatory submissions associated with IVD device use for assigned studies. ... **General Description:** The Senior Manager , Regulatory Diagnostics will lead the...for protocols, ICFs, and related study documentation. + Ensure regulatory submissions are maintained in compliance with… more
- BeiGene (San Mateo, CA)
- …responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions to meet aggressive timelines. The individual will ... **General Description:** BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent… more
- RWJBarnabas Health (Somerset, NJ)
- …workflow of the Department through establishing, tracking project milestones and coordinating submissions . Manager assists in obtaining regulatory approval ... Regulatory Planning Manager (Hybrid) - Somerset,...licensure and certificate of need processes. + Coordinates Departmental submissions to Department of Health such as licensure renewals,… more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Sr Manager Regulatory Affairs represents regulatory affairs for device ... and guidance documents, as well as technical reports, in support of regulatory submissions . + Advanced knowledge of US/EU medical device regulations. + Ability… more
- Kelly Services (Franklinton, NC)
- …, prepare regulatory documents, and lead submission meetings. + Oversee regulatory submissions to agencies and ensure timely approval. + Monitor, interpret, ... **Kelly(R) Science & Clinical is seeking** **a Regulatory Affairs Manager ** **for a position at cutting-edge client in** **Raleigh, NC.** **If you're passionate… more