- 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
- Cardinal Health (Columbus, OH)
- …plans, development of regulatory paths for products, preparing and managing regulatory submissions , and acting as a liaison between the organization and ... **Location** - Fully remote (candidates can reside nationwide) **Responsibilities** + ** Regulatory Submissions & Documentation** + Preparation, review, and… more
- AbbVie (Chicago, IL)
- …other document management systems as applicable), data collation and tracking of regulatory submissions . + Participate in development of internal working ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager of the Clinical Trial Strategy and Submission delivers clinical development… 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
- Vera Therapeutics (Brisbane, CA)
- …with external publishing vendors and consultants for on-time delivery of high-quality regulatory submissions . * Conduct final review of published submissions ... Title: Senior Manager , Regulatory Operations and Publishing Location:...publishing and QC tools (PDF Tools, TRS Toolbox), global regulatory submissions , or other experience directly related… 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
- Olympus Corporation of the Americas (Westborough, MA)
- …other than @Olympus.com, it is likely not legitimate._ **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market Olympus medical ... for Canadian Class 2, 3 or 4Device License submissions . Lead development of responses to regulatory ...ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States… 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
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works ... enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications… 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Vera Therapeutics (Brisbane, CA)
- …will be responsible for working with the cross-functional team to lead and support regulatory submissions and activities in the US and globally to support ... Job Title: Senior Manager , Regulatory CMC Location: Remote About...clinical products in early-to-late development to create high quality regulatory submissions that support product development strategy.… more
- Harvard University (Cambridge, MA)
- …as statistical project manager for IMPAACT's clinical trials involving regulatory submissions . Commitment to Equity, Diversity, Inclusion, and Belonging: At ... of related statistical experience, including with multi-center clinical trials involving regulatory submissions required; a combination of experience and… more