Regulatory Submissions Project Manager
Virtual Vocations Inc
Leading the planning and execution of major global marketing applications, the contract Regulatory Submissions Project Manager will manage critical NDA, BLA, MAA, and IND/CTA filings in a fully remote environment. Key responsibilities Lead end-to-end planning and execution of regulatory submissions, ensuring compliance and quality Develop and maintain integrated submission plans, milestones, and risk logs to support timely delivery Coordinate cross-functional content readiness and facilitate governance and communication with stakeholders Required qualifications Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related discipline 8+ years of relevant experience in pharmaceutical, biotechnology, or life sciences regulatory submissions project management Demonstrated experience leading major regulatory approval filings such as NDA, BLA, MAA, and IND/CTAs Experience in a matrixed global development environment supporting complex cross-functional teams
- ...Project Manager Apex Systems is seeking a Project Manager specializing in FDA medical device submissions to join our client for an immediate 9+ month contract opportunity, with high... ...Duties: Develop and implement regulatory strategies and processes to assure...RegulatoryContract workLocal areaImmediate startWorldwide
$110 per hour
...global marketing applications. You will manage critical NDA, BLA, MAA, and IND/CTA... ...to-end planning and execution of major regulatory submissions, including original marketing applications... ...leadership, program teams, Research project teams, and submission stakeholders...RegulatoryHourly payContract workTemporary workWork experience placementLocal areaRemote work- Puretek Corporation is seeking a Regulatory Project Manager in Los Angeles, CA to serve as a cross-functional coordinator between operations and quality teams. You will drive timelines and ensure that regulatory deliverables are complete and compliant across multiple client...Regulatory
$130 - $160 per hour
...are seeking an Environmental Permitting Project Manager to join our Planning, Permitting, and... ....), and other applicable New Jersey regulatory agencies, including Waterfront Development... ...phone calls and no employment agency submissions, please. First Environment is an Equal...RegulatoryFull timeTemporary workFor contractorsFor subcontractorWork at officeLocal areaRemote work- ...Seeking an experienced Regulatory Project Manager, this fully remote position will manage regulatory coordination for complex clinical research... ...and prepare all required study and regulatory documents for submission Collaborate with study monitors to collect and process...RegulatoryRemote work
- ...reports and environmental impact evaluations to support regulatory compliance ~ Experience managing project resources and coordinating with internal teams and... ...be considered unsolicited. Therefore, any such submissions will be considered property of CEC, with no associated...RegulatoryTemporary workWork at officeLocal area
$110k - $130k
...Senior Project Manager, Remediation Our client is a growing environmental consulting and contracting firm with a clear sense of... ...technical deliverables including work plans, reports, and regulatory submissions Client Development Cultivate and grow client...RegulatoryFor subcontractorLocal area- ...support innovative clinical development, the remote CMC Project Manager will oversee regulatory affairs delivery, coach team members, and drive... ...across multiple areas Prepare strategic development and submission plans Act as a trusted partner in business development...RegulatoryRemote work
- ...Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role combines technical writing expertise with project management skills to drive Chemistry,...RegulatoryWork at office
- ...Job Title: Operations Project Manager L ocation: Jersey City NJ 07310 Duration:... ...Responsibilities: Preparation of various daily regulatory reporting of the following (but not... ...processing Daily Blue sheet Submission and Review. Daily Statements &...RegulatoryContract workImmediate start
- NEPA Project Manager Job Locations US-NC-Charlotte Category Ecological Services... ...ensuring high-quality deliverables and regulatory compliance. At CEC, every team... ...considered unsolicited. Therefore, any such submissions will be considered property of CEC,...RegulatoryFull timeTemporary workWork at officeLocal area
- ...Project Manager (Consultant) We are seeking an experienced Project Manager to support the... ...testing, and Premarket Approval (PMA) submission of a Class III long-term implantable medical... ..., manufacturing readiness, and regulatory submission activities. The Project Manager...Regulatory
$73.71k - $95.55k
...opportunity SWCA is currently seeking a Project Manager - Mining to join our nation-wide... ...applicants and will carefully consider each submission. What you will accomplish Manage... ...with challenging environmental and regulatory requirements. Identify and...RegulatoryFull timeImmediate startRemote workFlexible hoursNight shift- ...DEKA Research & Development has an immediate opening for a Regulatory Affairs Project Manager to contribute to a dynamic, medical device research and... ...regulatory requirements and leading the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other...RegulatoryWork experience placementImmediate start
- Senior Project Manager Environmental Job Locations US-OK-Oklahoma City Category... ...preparation of technical documents, and regulatory negotiations, while delivering on time... ...considered unsolicited. Therefore, any such submissions will be considered property of CEC,...RegulatoryFull timeTemporary workFor contractorsWork at officeLocal area
- ...late clinical-stage rare disease company is seeking a Director/Senior Director of Regulatory Affairs. In this strategic role, you will manage global regulatory strategies for submissions in the US, EU, UK, and Japan. You will lead major submissions, engage with regulatory...Regulatory
- Solid Waste Project Manager Job Locations US-MO-St. Charles Category Waste Management... ...construction, ensuring quality, regulatory compliance, and client satisfaction, while... ...unsolicited. Therefore, any such submissions will be considered property of CEC, with...RegulatoryFull timeTemporary workFor contractorsWork at officeLocal area
- 920-Projects/Engineering 1145-920 Project Manager Under direction, plans, schedules, budgets, and manages construction... ...Review construction document submissions and provide written comments on... ...activities and interfaces with regulatory agencies, utility providers,...RegulatoryContract workFor contractorsWork at officeFlexible hours
- ...seeking a highly organized Senior Regulatory Affairs Associate to coordinate regulatory submissions across regions. The successful candidate will manage submission activities, ensuring timely... ...affairs, along with strong project management skills and fluency in English...Regulatory
- ...Gan & Lee Pharmaceuticals is seeking a Regulatory Affairs professional to support the implementation of regulatory strategies. Responsibilities include ensuring compliance for product submissions and regulatory interactions. The ideal candidate will have a Bachelor of...Regulatory
$38 - $57 per hour
...Position Summary The Project Manager provides support to our Electrical Testing and Field... ...proposals and quotes to insure timely submissions. Conduct client communication in a... ...conducted in strict compliance of all regulatory law. Observe all safety rules and...RegulatoryHourly payFull timeWork at officeRelocationRelocation packageFlexible hoursShift workNight shiftWeekend work- ...Wastewater Permitting and Compliance Project Manager Location: Arlington, VA, US, Cleveland... ...expertise to lead complex regulatory programs, mentor staff across multiple... ...the U.S.; Manage the preparation and submission of permit applications and compliance...RegulatoryFull timeTemporary workFor contractorsWork at officeLocal areaWorldwideFlexible hours
- ...Global Regulatory Strategy Lead - Oncology Act as responsible for... ...and pathway for one/several projects in oncology. Responsible for... ...quality global regulatory submissions that support development strategies... ...Reg, CMC Reg, submissions management, labelling, CTA/IND, as...Regulatory
- ...Client is seeking an experienced CMC Project Manager to provide execution leadership across... ...activities. This engagement is aligned to regulatory filing milestones, including PPQ... ..., and milestone execution through BLA submission and related post‑PPQ activities. This...RegulatoryContract workImmediate startRemote work
$130k - $140k
...Project Manager, Regulatory Affairs (VALVE) Irvine, CA – Corporate Office Overview Salary Range $130,000.00 - $140,000.00 Salary Position... ...Summary: Responsible for timely preparation and submission of organized, scientifically valid global regulatory affairs...RegulatoryFull timeWork at officeShift work- ...Apr is seeking a Contract Senior Manager, Regulatory Affairs, to oversee the submission of regulatory documents to National Health Authorities. This role requires a minimum of 5 years of regulatory affairs experience in the pharmaceutical or biotechnology sector. The...RegulatoryContract work
- ...an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for pharmaceutical products. This pivotal role... ...Regulatory Affairs and a proven track record of managing ANDA, IND, NDA submissions. This position is remote...RegulatoryRemote work
- ...Position Overview: The Project Manager is responsible for managing development-heavy customer... ..., formula timelines, and client submissions while serving as the primary liaison between... ...testing, artwork approvals, and regulatory timelines Ensure client timing is maintained...RegulatoryWork at office
- ...Operations Project Manager Examinetics is hiring an Operations Project Manager to join our... ...timekeeping, PTO, and expenditure submissions for all direct reports in accordance with... ...companies partner with Examinetics to achieve regulatory compliance, minimize productivity loss...RegulatoryDaily paidContract workWork at officeFlexible hoursDay shift
- ...Project Manager Provides tools and methods and aligns cross-functional plans for the management of products... ...received, processed, & executed through our systems Regulatory readiness – drive QRC to ensure all submissions are completed, technical files is completed,...Regulatory
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