US Regulatory Director - Oncology Strategy
AstraZeneca
AstraZeneca seeks a Regulatory Affairs Director to shape US regulatory strategy for oncology therapies, accelerating innovation and patient access. You will lead regional regulatory initiatives across development, submission, approval and lifecycle management in a global matrix environment. You will drive major submissions (INDs, NDAs, BLAs), engage health authorities, and guide cross-functional teams through complex programs with strategic insight and strong communication skills.
#J-18808-Ljbffr- Join AstraZeneca’s Oncology Business Unit (OBU) in a role where strategy meets scientific ambition. As a Director, OBU Strategy, you will assist in the creation and implementation of... ...section in the application form.SummaryLocation: US - Gaithersburg - MDType: Full timeSuggestedHourly payFull timeTemporary workFlexible hours
- ...AstraZeneca seeks a Director of Regulatory Affairs Strategy for cell therapy programs spanning oncology, immune-mediated, and rare diseases. This role shapes global regulatory pathways from expedited designations through submissions and post-approval activities, partnering...Suggested
- Do you want to shape the future of oncology medicines and influence regulatory decisions that impact patients... ...medicines. As a Regulatory Affairs Director, you will play a pivotal role in defining and executing US regulatory strategies that accelerate innovation and bring...SuggestedHourly payFull timeTemporary workWorldwide
- AstraZeneca in Gaithersburg, MD seeks a Director Oncology Engagements and Above-Brand Strategy to identify, lead and direct external Oncology initiatives across brands and tumor types. You will partner with US and Global Oncology teams, manage cross-functional workstreams...Suggested
$151.08k - $226.62k
Associate Director, Oncology Business Unit Strategy - GaithersburgAt AstraZeneca, our Oncology Business Unit (OBU) is pushing the boundaries of science to... ...please complete the corresponding section in the application form.SummaryLocation: US - Gaithersburg - MDType: Full timeSuggestedFull timeTemporary workWorldwide$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth... ...path for programs that span oncology, immune-mediated and rare diseases—translating... ...medicines. In-person working gives us the platform we need to connect,...Hourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...Vacancy Name Director, Global Market Access Strategy, RWE, HEOR and Pricing Vacancy... ...capabilities for the USA market in oncology The Director will be... ...Markets, and the US Commercial and Medical Affairs... ..., Clinical Development, Regulatory, Biostats and Project...Permanent employmentLocal areaFlexible hours
$210.86k - $242.79k
Director, Patient Services Strategy, US Cell & Gene Therapy Office Location: Gaithersburg, MD (3 days minimum per week) Remote is not available for this... ...week in office in Gaithersburg. Preferred Requirements Oncology, Rare Disease, Specialty Pharmacy, or Market Access...Hourly payTemporary workWork at officeRemote work3 days per week- Associate Director, Research Strategy and Operations, Hematology R&DAstraZeneca is a global, science-led... ...multiple scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage... ...the application form.SummaryLocation: US - Cambridge - MA; US - Gaithersburg -...Hourly payFull timeTemporary work
- 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... ...benefits and a pathway to influence oncology programs and interactions with Health Authorities...
- ...AstraZeneca seeks a Director to build and scale global patient engagement strategies within oncology and biopharmaceutical programs. This role integrates patient insights, behavioral science, and AI technologies to design evidence-based interventions, establish value...
$186.23k - $279.35k
Location: Seaport, Boston Reports to: Senior Director, Global Regulatory Strategy About Alexion For over 30 years, Alexion has been dedicated to transforming... ...step. Role Overview:The Director, Regulatory Affairs US lead will be accountable for the development,...Full timeTemporary workWork at office$135.62k - $203.44k
...Seaport, Boston or Gaithersburg, MarylandReports to: Senior Director, Global Regulatory Strategy About Alexion For over 30 years, Alexion has been... ...step. Role Overview:The Senior Manager, Regulatory Affairs US lead will be responsible for leading, planning, preparing...Full timeTemporary workWork at office- ...a finance leader in Gaithersburg to own Gross-To-Net forecasting for its US Oncology unit. You will work as a strategic partner to Policy, Market Access, Government Pricing, and Contract Strategy, shaping the financial backbone for pricing, contracting, and patient access...Contract work
$196.7k - $353.4k
The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters... ...and license maintenance - preferably from at least both US and EU Direct experience of leading regulatory authority meetings...Permanent employmentFull timeWork at officeWork from home$138.75k - $231.25k
Global Regulatory Affairs Manager, Oncology We create a place where people can grow, be their best, be safe,... ...execute global and regional regulatory strategies for oncology assets, ensuring... ...position ranges $138,750 to $231,250. The US salary ranges take into account a...Work at officeLocal areaRemote work$147.02k - $220.53k
...AstraZeneca seeks an Associate Director to develop and implement contract strategies for its oncology portfolio. The role involves financial analysis, market access optimization, and cross-functional collaboration to support pricing and access objectives across key customer...Contract work$147.02k - $220.53k
...The Oncology therapy area at AstraZeneca is unparalleled. We have built and strategically... ...Assist in creating and defining contract strategies that include financial analytics and... ...launch and in-line products. The Associate Director of Contract Strategy may partner with...Contract workTemporary workShift work$189.5k - $235k
Vacancy Name Director, Regulatory Affairs-Global Regulatory Lead Vacancy No VN... ..., PA, Oxford, UK, Remote, US Department Regulatory Affairs... ...Regulatory scientific and tactical strategy development, IND development... ...regulatory environment for oncology, antifectives, autoimmune...Full timeWork at officeLocal areaRemote workWorldwideNight shift$151.08k - $226.62k
...Associate Director supporting AstraZeneca's Oncology Business Unit in strategic planning and business development. The role involves portfolio analytics... ...to guide investment decisions and commercialization strategies for oncology treatments. Responsibilities Evaluate...- ...a Senior Strategic Programs Manager within the International Government & Regulatory Affairs team to drive strategic initiatives and manage high-priority programs across locations outside the US. You will translate complex information into clear insights, support engagements...
$267.91k - $401.87k
...collaboration with AstraZeneca’s Therapeutic Area Units. The Strategy and Commercial Executive Director, Cell Therapy Strategy and Commercial (CTSC), is a high-... ...life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge...Full timeTemporary workWork at officeFlexible hours3 days per week$210.86k - $242.79k
...AstraZeneca seeks a Director to develop and execute the US patient services strategy for its cell and gene therapy portfolio. This role involves designing support... ...convert complexity into executable strategy ~ Oncology, rare disease, or specialty pharmacy experience preferred...- ...USMA Business Planning to own the integrated US Medical Affairs planning cycle. This enterprise-facing role drives strategy, portfolio, budgets and milestones with AI-enabled... ...capabilities, partnering with the Finance Director and CIME leaders. You will shape how...
- Supernus Pharmaceuticals, Inc. is seeking a Director of Intellectual Property to lead the... ...trademarks, and copyrights. The role oversees US and worldwide patent and trademark... ...inventions, invention disclosures, and IP strategy, with responsibility for docketing, annuity...Worldwide
$155.52k - $233.28k
...experience and deliver measurable impact across Oncology and Biopharmaceutical indications. As... ...and scale our global patient engagement strategy, including complex patient solutions and... ...medicines. In-person working gives us the platform we need to connect, work at...Hourly payTemporary workWork at officeWorldwideFlexible hours3 days per week$150k - $200k
...executive team and directly influence product, market, and company strategy at a growing technology hardware company. Own the full... ...only product marketing backgrounds will not qualify. About Us We are a growing technology hardware company developing innovative...Full timeWork at officeRemote work3 days per week$120.05k - $171.07k
...key role in translating the organization’s strategy into tangible results. This position... ...programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-... ...time monitoring of performance, allowing us to rapidly adjust to signals as needed....Full timeWork at officeWorldwide- ...CRB is seeking a Director, Oligo & Peptide Market Segment Leader to drive long-term global... ...will lead a cross-functional team, shape strategy, and expand CRB’s presence in oligo and peptides... ...win business, and deliver superior design excellence. #J-18808-Ljbffr Jobleads-USWorldwide
- ...a Senior RegulatoryAffairs Director you’llplay a pivotal role in... ...changing patients’ lives.R&D Oncology drives late‑stage development... ...of the global regulatory strategy for a product/group of products... ...as GRL across major regions (US and EU) including leading response...Hourly payTemporary workFlexible hours
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