Strategic Regulatory Affairs Manager
Precigen
Precigen, based in Germantown, MD, seeks a Senior Manager/Manager, Regulatory Affairs to lead regulatory strategies for drug development programs, guiding IND/BLA submissions and regulatory intelligence. The role works with QA, CMC, Preclinical and Clinical teams to ensure regulatory compliance across US and global agencies. The position demands strong knowledge of global regulations, experience with eCTD, and the ability to communicate regulatory goals and timelines to cross-functional teams. #J-18808-Ljbffr Precigen
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...is a senior global leadership role in Regulatory Affairs responsible for defining and executing... ...manufactured and developed at QIAGEN.Provide strategic regulatory guidance and run internal... ...goals to meet business objectives.Manage the annual Global Regulatory Affairs operating...SuggestedFull timeLocal areaWorldwide$276k - $414k
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Regulatory Affairs Director - OncologyLocation: USA - Gaithersburg MDWould you like to apply your... ...Affairs Director (RAD) provides strategic and operational regulatory leadership... ...development, commercialization and life cycle management of assigned oncology products. Serves...SuggestedHourly payFull timeTemporary work3 days per week$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...the highest level. Could you be the strategic voice that anticipates risk, seizes... ...driven choices.Delivery and Milestone Management: Oversee all regulatory deliverables...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...risks and mitigation plans to senior management.Milestone Delivery: Support delivery... ...Regulatory Strategy Team, demonstrating strong strategic, communication, and collaboration...Hourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- A global staffing solutions firm is seeking a Strategic Project Manager to provide business planning for their US Medical Affairs teams. The role requires strong project management, collaboration with leadership teams, and ability to drive operational excellence. Ideal...
$150.1k - $225.15k
...reality. The Associate Director Promotional Regulatory Affairs will work with a with a cross-... ...material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast... ...ethics and high concern for standards Strategic and analytic thinking and decision-...Temporary workWork at officeFlexible hours3 days per week- ...oncology medicines and influence regulatory decisions that impact... ...medicines. As a Regulatory Affairs Director, you will play a pivotal... ..., approval and lifecycle management activities while partnering... ...Director, you will provide strategic and operational regulatory leadership...Hourly payFull timeTemporary workWorldwide
- ...passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us... ...the development, commercialization and life cycle management of assigned products. Serves as the global...Worldwide
$120.05k - $171.07k
...collaborative work environment.Brief Job Overview The Senior Strategic Realization Program Manager plays a key role in translating the organization’s... ...programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure...Full timeWork at officeWorldwide$266.6k - $399.9k
...modalities for patients. As part of our Regulatory Affairs team, you will play a crucial role in... ...and a realist while providing global strategic regulatory expertise and oversight to... ...a health authority. Experience in managing people in a matrixed organizational structure...Hourly payTemporary workWork at officeFlexible hours3 days per week- ...charitable goals into lasting impact through philanthropic guidance, strategic giving, and stewardship. The Associate Director, Foundation... ..., and strengthen donor engagement ~ Develop and manage an editorial calendar aligned with Foundation priorities and coordinated...Relocation3 days per week
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...passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us... ...the development, commercialization and life cycle management of assigned products. Serves as the global...Hourly payTemporary workWorldwide3 days per week- Your Role: The Sr. Manager, Trade Compliance & Logistics is a strategic leadership role responsible for developing, leading... ...to the United States. Drive Regulatory/ Operational Oversight: Oversee import... ..., quality, legal and Regulatory Affairs to ensure timely and compliant...Full timeLocal area
$145k - $160k
Strategic Account Manager - Central Region Ready to shape the future of science and global health? ATCC, a leading nonprofit biological resources and standards organization, is seeking a dynamic Strategic Account Manager (SAM) to drive growth and build lasting partnerships...Contract workRemote work- AstraZeneca in the United States is seeking an Executive Regulatory Science Director, Respiratory & Immunology to lead global regulatory... ...health authorities to accelerate approvals while ensuring strategic alignment with portfolio goals. The role demands senior leadership...Work at officeFlexible hours
- AstraZeneca seeks a Regulatory Affairs Director - Oncology to lead global regulatory strategy and submissions from Gaithersburg, MD. You will... .... You will mentor a Global Regulatory Strategy Team, craft strategic documents, and own milestones to ensure robust, compliant...
$88.88k - $122.21k
...student-centered leader to serve as the Strategic Student Success Initiatives Director. This... ...unique needs while supporting project management and assessment efforts. Working collaboratively... ...with institutional leadership, Academic Affairs, Counseling and Advising, Institutional...Full timeRemote workMonday to FridayFlexible hoursAfternoon shift1 day per week$101.87k - $127.25k
...collaborative work environment.Brief Job Overview This role serves as a key driver of strategic initiatives within the International Government & Regulatory Affairs department, leading project management efforts across high-priority programs and ensuring effective tracking of...Full timeWork at officeWorldwide- The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused... ...Director is expected to: Independently manage clinical regulatory writing activities...
- Aramark is seeking a Strategic Sourcing Manager for Hospitality Room Supplies, currently listed as REMOTE with a Rockville, MD base. The role focuses on managing supplier relationships, contracts, and category strategy within Rooms Amenities to drive cost savings and value...Remote job
- Adventist HealthCare seeks an experienced Reimbursement and CDM Manager to oversee reimbursement activities for HSCRC and related regulatory reporting. You will lead CDM governance, pricing, and charge capture across the enterprise, collaborating with Revenue Integrity...
- Montgomery County Coalition for the Homeless (MCCH) seeks a Director of External Affairs & Government Relations to lead external engagement, public policy advocacy, and strategic communications. The role advances funding, partnerships, and brand visibility to end homelessness...
- Job Details: Corporate Division - Rockville, MD 20850. The National Strategic Sourcing Manager plays a critical role in advancing enterprise-wide procurement strategy by developing and managing high-value regional and national supplier relationships. This role partners...For subcontractorShift work
$186.23k - $279.35k
...breakthrough programs, where your regulatory leadership translates... ...Global CMC Strategy: Provide strategic guidance during all stages of... ...Intelligence and Risk Management: Interpret global regulations... ...documents; represent CMC regulatory affairs on product teams and in...Hourly payTemporary work3 days per week$186.23k - $279.35k
...Are you ready to transform Regulatory Intelligence into actionable insights for product... ...Respiratory & Immunology (R&I) Regulatory Affairs team, you will play a crucial role in bringing... ...Proficiencies in data impact analysis, strategic thinking, creative problem solving, and...Hourly payTemporary workWork at officeFlexible hoursShift work3 days per week$133.04k - $199.56k
...Clinical Regulatory Writer, Associate Director / Manager Location: Boston, MA OR Gaithersburg, MD- Hybrid (3 days onsite) Introduction to role: Are... ...leadership to drug projects, authoring strategically important clinical-regulatory documents that align with...Hourly payTemporary workWork at officeFlexible hours3 days per week$267.91k - $401.87k
...disciplined, insights‑driven valuations and strategic recommendations to C‑suite stakeholders... ...decisive and proactive; must be able to manage multiple priorities in a fast-growing... ...Japan, China)Thorough understanding of regulatory and pricing dynamics in major marketsThe...Full timeTemporary workWork at officeRemote workFlexible hours3 days per week
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