Regulatory Publishing Manager
Talent Groups
Experience in industry standard publishing software and validation systems Knowledge of types of Global HA submissions and their requirements and guidelines Ability to work with firm deadlines and adapt quickly to changing requirements and priorities Ability to prioritize portfolio of publishing activities on programs Ability to educate and train other team members and influence cross functional stakeholders in submission ready concepts Strong organization, written/verbal communication, and attention to detail Knowledge of health authority procedures/guidance's regarding electronic submissions Highly Skilled in use of Electronic Document Management Systems Ability to balance multiple tasks to meet priorities and timelines Education and Experience: Bachelor’s Degree in life sciences or technology area Typically requires 7 Years of eCTD publishing experience or the equivalent combination of education and experience #J-18808-Ljbffr Talent Groups
$85 - $92 per hour
Job Description The Regulatory Publishing Senior Manager is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The role is accountable for leading publishing...SuggestedContract workMonday to FridayShift work$172.5k - $222.5k
...new ideas are encouraged and everyone is a stakeholder.What you’ll be responsible for: Circle is looking for a Senior Manager to join the Regulatory Assurance team who will help to create a central global function focused on developing a best in class compliance management...SuggestedFlexible hours- Job-ID31521196Reference25-04484 The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the...Suggested
- ...Job Overview: We are seeking an experienced and highly motivated Regulatory Manager to join our Regulatory Affairs team. In this role, you will be responsible for developing and executing regulatory strategies to ensure compliance and successful product approvals. You...SuggestedContract workWork at office
- ...of the Dentsply Sirona Essential Dental Solutions team This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products This role manages and submits 510ks for the products and manages communications with FDA including...SuggestedWork at office
- Job-ID31618053Reference25-04665 Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures,...Flexible hoursNight shift
- ...Radical Ventures and NVIDIA. Learn more about our vision, team, and backers at About the Role We’re looking for a Policy & Regulatory Affairs Manager to help shape and execute our policy and regulatory strategy at a critical moment of growth. As demand accelerates and...Work from homeFlexible hours2 days per week
$70 - $75 per hour
...Regulatory Affairs Manager / Senior ManagerThis role supports global regulatory activities for innovative development programs within a dynamic biopharma environment. Reporting to the Senior Director of Regulatory Affairs, you will help drive high-quality regulatory submissions...Contract workTemporary workWork at officeLocal areaMonday to Friday$148.5k - $174.7k
...discover what you excel at—all from Day One.Job DescriptionThe Regulatory Administration group supports fund clients through preparation... ...investment companies and related regulatory requirements-- Ability to manage multiple tasks simultaneously in a deadline driven environment...Work at officeLocal areaRemote workFlexible hours3 days per week- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+...
- Vertex Pharmaceuticals Incorporated in Boston is seeking a Chemistry Manufacturing Controls Manager to lead regulatory CMC activities for investigational and commercial products. You will review CMC submissions, develop global regulatory CMC strategies, and serve as the...
$130k - $180k
...commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. They are seeking a Regulatory Strategy Manager (or Senior Manager) to support global regulatory activities for their investigational products. You will prepare...Full timeRelocationFlexible hours3 days per week- ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...
- Partner closely with the Director of Regulatory Affairs to define and implement regulatory strategies for new product development, product modifications, and lifecycle management of Class II medical devices. Provide regulatory guidance during product development to ensure...
- Arbor Biotechnologies, based in Cambridge, MA, is seeking a Manager, Regulatory Affairs, to support regulatory execution across internal and partnered programs, health authority interactions, and cross-functional activities toward IND/CTA submissions. You will lead regulatory...
- SHARE THIS JOB: Quality Assurance and Regulatory Affairs Manager Location: SOMERVILLE, MA Type: Full-time COMPANY BACKGROUND At Taza Chocolate we make stone ground, organic chocolate. We want our cacao’s complex flavors to shout loud and proud. That is why we stone...Hourly payFull timeRemote work
$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory... ...teams and GRA leadership. Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics,...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$196.7k - $353.4k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader... ...external to the company Demonstrated competence in employee management and development Knowledge of and broad experience with regulatory...Permanent employmentFull timeWork at officeWork from home- Job DescriptionGeneral Summary:The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed... ...be responsible for the strategic development and lifecycle management of labeling for that/those area(s), including TLPs.Knowledge...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week
$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical... ...of programs within the T1D portfolio. This position will manage a group of global/regional regulatory professionals with program...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$108k - $130k
...stage of our journey as we continue to grow. Job Description The Opportunity: We, at Flywire, are seeking a Regulatory Reporting Manager - Money Transmitter Licensing - that will oversee money transmitter filings for our USA licensed entity. This role is...Full timeTemporary workLocal areaImmediate start$200k - $265k
...opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage...Full timeTemporary workWork experience placementWork at officeWorldwide$170k - $267.5k
Who we are looking forThe Global Head of Regulatory Examination Management is a senior leadership role within the Global Regulatory Liaison Office (GRLO) responsible for leading the firm’s global regulatory examination program, including the governance, coordination, and...Full timeTemporary workWork at officeLocal areaFlexible hours- ...Chief Medical OfficerPosition SummaryThis individual will lead regulatory strategy and execution for growing clinical-stage oncology pipeline... ...development plans, CMC changes, and clinical trial expansion. Manage external regulatory consultants and vendors as needed....2 days per week3 days per week
$177k - $278.08k
...therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...regulatory compliance. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact...Minimum wageTemporary workLocal areaRemote workWorldwide$110k - $160k
Compliance Manager Position, $110,000 - $160,000, discretionary annual bonusSenior professionals with 10+ years may command higher compensation... ...strategies. This role serves as a critical bridge between regulatory requirements and business operations in a dynamic asset...Work at officeLocal areaVisa sponsorship$215k - $235k
...sounds like you then please read on!About the Role: The Director of Regulatory Affairs is responsible for leading regulatory strategy and... ...cross functional data narratives to support designation requests.Manage submission, agency correspondence, and follow up related to...- ...Reference26-00886 Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...will contribute: With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid...
$171k - $273k
...Job TitleHead of Regulatory, AM & DJob DescriptionHead of Regulatory, Ambulatory Monitoring & DiagnosticsThe Head of Regulatory for Ambulatory... ..., talent development, succession planning, performance management, and functional leadership to ensure regulatory excellence and...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$190.4k - $285.6k
...:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory... ...for authoring, review, data traceability, and knowledge management.Ensures programs are appropriately resourced and accountable for...Full timeSummer workRemote workFlexible hours2 days per week
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