Director, Regulatory Affairs
AstraZeneca
AstraZeneca GmbH is seeking a regulatory leader in Gaithersburg, MD, to oversee the global CMC strategy for cell and gene therapies. You will ensure the delivery of high-quality submissions and navigate complex health authority interactions.
The ideal candidate will possess extensive regulatory experience, strong leadership skills, and a life sciences background. The role offers a competitive salary, benefits, and opportunities for professional growth.
#J-18808-Ljbffr$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent...SuggestedFull timeLocal area$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: NYC, NYGaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory direction for first-in-class cell therapies...SuggestedHourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$150.1k - $225.15k
...here means being entrepreneurial, thinking big and working together to make the impossible a reality. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help...SuggestedTemporary workWork at officeFlexible hours3 days per week$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough...SuggestedHourly 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, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care...SuggestedHourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...Zenith LifeScience is seeking a Regulatory Affairs Director to provide strategic and operational regulatory leadership across the development, commercialization and lifecycle management of a diverse product portfolio. The RAD will serve as global regulatory lead on select...
$178.53k - $267.8k
Regulatory Affairs Director - OncologyLocation: USA - Gaithersburg MD, Canada- MissisaguaWould you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?At...Hourly payFull timeTemporary work3 days per week- ...Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational... ...considered an equal partner in the business. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory...Worldwide
- POSITION SUMMARY: Based in Germantown, Maryland Precigen is seeking a highly motivated and experienced Associate Director/Senior Manager, Regulatory Affairs(level based on candidate experience). This role is responsible for knowledge and application of global regulations...Work at office
$139.45k - $198.72k
...compliance needs, monitor sanctions-related developments and exposure, tariffs, and build longer-term plans to address emerging regulatory changes. This individual will take a strategic view to resolve complex import, export, tariff and sanctions compliance issues, including...Full timeWork at officeImmediate startWorldwide$190.8k - $300.3k
Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust... ...include, but are not limited to:Report to Executive Director or Associate Vice President, General MedicineOversee the global...Full timeFor contractorsLocal areaWorldwideFlexible hours- ...want to shape the future of oncology medicines and influence regulatory decisions that impact patients globally?At AstraZeneca, we... ...science and delivering life-changing medicines. As a Regulatory Affairs Director, you will play a pivotal role in defining and executing US...Hourly payFull timeTemporary workWorldwide
- .... Imports are mostly from Germany to the United States. Drive Regulatory/ Operational Oversight: Oversee import/export applications, registrations... ...as a liaisonwith supply chain, quality, legal and Regulatory Affairs to ensure timely and compliant product movement. Leads audits,...Full timeLocal area
$90k - $110k
Director of Compliance (Multi-Family Affordable Property Management)The Compliance Director provides leadership and support to the compliance... ...Development (HUD), Public Housing Agencies (PHAs)and other regulatory agencies Provide an audit, review, and pre-occupancy/...Full timeInterim roleWork at officeLocal areaMonday to FridayEarly shift$208.06k - $262.15k
.... USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-... ...ResponsibilitiesYes, the followingdirect reports:Director / Sr Manager, International regulatory... ...Number: SENIO003504Job Category: Ext. Affairs, Regulatory, \& CommunicationsSchedule:...Full timeWork experience placementWork at officeWorldwide- AstraZeneca GmbH in the United States is seeking a Senior Regulatory Affairs Director to lead global regulatory strategy for complex products, driving rapid approvals and advantageous labeling. You will chair the Global Regulatory Sub-team with regional input, manage regulatory...
- AstraZeneca in Gaithersburg, MD, seeks a Director Regulatory Intelligence (RID) to translate emerging regulatory signals into choices for pipeline and marketed assets. Based at our R&I site, you’ll join a diverse team to deliver capabilities supporting strategy and portfolio...
- AstraZeneca seeks a Regulatory Affairs Director - Oncology to lead global regulatory strategy and submissions from Gaithersburg, MD. You will drive cross-functional teams, shape engagement with health authorities, and influence labeling across markets to accelerate patient...
- 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...
- ...Associate Director, Clinical Regulatory Writing (CReW) Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern...
$101k - $154k
...performing the day to day activities required to operate a fully effective export compliance program to ensure company compliance with US regulatory and internal policy requirements relating to export licensing, exemption usage, export training and recordkeeping. Worker Type...Permanent employmentContract workFor contractorsWork experience placementWork at officeRemote work$85k - $125k
...leading supplier of high-quality Lentiviral vectors for research and clinical use.We are seeking an exceptional team member to provide regulatory and product development support in a dynamic small company setting.If you are comfortable on the cutting edge and passionate...For subcontractor$69.8k - $100.05k
...full-time Division: Clinical Research Directorate Facility: Rockville: 9800 MedCtrDr Location... ...DDD supports efficient preparation of regulatory materials and documentation needed for... ...Roles/Responsibilities The Regulatory Affairs Associate will support regulatory strategy...Full timeContract workPart timeFor contractorsWork at office- The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical... ...and approvals. The Clinical Regulatory Writing Associate Director is expected to: Independently manage clinical regulatory writing...
$137.7k - $210k
...external GMP operations, including deviations, CAPA, OOS/OOT, change control, SCARs and product complaints.Supports and may host regulatory inspections and partner audits.Perform other quality duties as assigned.Qualifications Education, Credentials & Experience Bachelor...Full timeCasual workLocal areaFlexible hours- ...location (CA, OR, WA, CO, IL, GA, MD, VA, DC)Technical Summary:The Director, Marketing Compliance & Governance provides strategic leadership for enterprise-wide marketing compliance, governance, and regulatory readiness programs, ensuring all marketing communications,...Work experience placementFlexible hours
$250k - $300k
...together, let's shape the future of biological discovery. About the opportunity This is a senior global leadership role in Regulatory Affairs responsible for defining and executing the worldwide regulatory strategy for QIAGEN's IVD (In Vitro Diagnostics) and Life Sciences...Full timeLocal areaWorldwide$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... ...Affairs as a Regulatory Intelligence Director. This role sits at the intersection of...Hourly payTemporary workWork at officeFlexible hoursShift work3 days per week- ...Title: Head of Regulatory Bioanalysis Location: Gaithersburg, Maryland, US Hybrid Working: 3 days per week in the office Bold Disruptors. Push the boundaries of science. Fearlessly break new ground. Are you ready to work at the cutting-edge, where scientific...Hourly payTemporary workWork at officeWorldwide3 days per week
$186.23k - $279.35k
...positions you at the center of breakthrough programs, where your regulatory leadership translates pioneering science into high-quality... ...health authority briefing documents; represent CMC regulatory affairs on product teams and in agency interactions; ensure submission...Hourly payTemporary work3 days per week
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