Director of Regulatory Strategy - NDA & Oncology
EPM Scientific
EPM Scientific seeks a Director of Regulatory Affairs for a commercial-stage biotechnology company focused on oncology and hematology, supporting an expanding portfolio from development through commercialization. The role centers on leading NDA submissions, regulatory strategy, and lifecycle management, offering high visibility across cross-functional teams and impact on multiple assets at critical regulatory milestones. #J-18808-Ljbffr EPM Scientific
- 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...Suggested
- ...stage biotechnology company focused on oncology and hematology is seeking a Director of Regulatory Affairs to support an expanding... ...individual will play a key role in regulatory strategy and execution, with a primary focus on leading NDA submission activities and supporting...Suggested
$178.53k - $267.8k
Regulatory Affairs Director - Oncology Location: USA - Gaithersburg MD Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the... ...in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions...SuggestedHourly payTemporary work3 days per week- MSD Malaysia seeks an Executive Director, Enterprise Regulatory Policy Strategy to set strategic direction for enterprise regulatory policy across regions and markets. The role requires deep regulatory expertise and the credibility to influence policy priorities in support...Suggested
$122.12k - $183.18k
...The ForecastingSenior Manager, Oncology leads the US forecasting process for one of the... ...performance to ultimately guide commercial strategy and decision-making. Strong analytical... ...reports to the Integrated Insights Senior Director for the Tumor Franchise and sits within...SuggestedTemporary work$186.23k - $279.35k
...passionate about science and experienced within regulatory affairs and drug development? Do you... ...get involved in the global regulatory strategies and support the research, development... ...the business. The Regulatory Affairs Director (RAD) provides strategic and...Hourly payFull timeTemporary workWorldwide3 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... ...development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology. Broad background...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$267.91k - $401.87k
...impact at AstraZeneca by leading strategy for our industry-leading oncology pipeline. Collaborate with R&D and... ...eradicating cancer. As Executive Director, Oncology Business Unit (OBU) Strategy... ...) Thorough understanding of regulatory and pricing dynamics in major markets...Full timeTemporary workWork at officeRemote workFlexible hours3 days per week- AstraZeneca GmbH is seeking a Director of Business Planning to join their Business Planning Operations... ...leading cross-functional initiatives within Oncology and Hematology. The successful candidate will implement business strategies, optimize operational workflows, and drive...
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta... ...development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology. Broad background...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$231.9k - $365k
Job DescriptionThe Science and Regulatory Policy team is responsible for developing our company’s science and regulatory... ...thought leaders and regulators. The Executive Director, Enterprise Regulatory Policy Strategy provides strategic direction for our company's enterprise...Full timeFor contractorsLocal areaFlexible hours$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients, aiming... ...global and/or regional regulatory strategy(s) and their execution for assigned asset... ...Minimum of two years of experience in Oncology (Hematology or Solid Tumor) regulatory...Full timeLocal area- Currently looking to identify a Director Business Planning to join the... ...role within the Global Oncology and Hematology Business Unit... ...planning processes, e.g. Tumor Strategy Plans (TSPs) and Brand Strategy... ...Healthcare ecosystem stakeholders; Regulatory and policy organizations. Our...Hourly payTemporary workLocal areaRemote workVisa sponsorshipWork visa3 days per week
$221.93k - $369.88k
...Summary As a therapeutic head within Labelling Strategy and Governance, you will lead a global labelling team for oncology products. You will engage with key... ...trust with stakeholders, and deliver practical regulatory solutions. This role offers visible impact, professional...Local area2 days per week3 days per week- The role is responsible for line management of Global Regulatory Strategy (GRS) Therapy group (TG) staff and may also involve individual support for projects as a regional director or GRL. The role reports directly to the GRS TG Portfolio Lead. The Regulatory Director/...Local area
- AstraZeneca in the United States is seeking an Executive Regulatory Science Director, Respiratory & Immunology to lead global regulatory strategy across development stages. You will mentor RADs and engage with health authorities to accelerate approvals while ensuring strategic...Work at officeFlexible hours
- GSK in Rockville, MD seeks a Regulatory Director/Team Leader to oversee the Global Regulatory Strategy (GRS) Therapy group and provide senior regulatory leadership for development programs. The role includes line management, mentoring, and ensuring robust regulatory strategies...
- USP seeks a Senior Director, Global Programs (Regulatory and Laboratory) to lead the growth of externally funded regulatory and laboratory programs. The role focuses on building long-term strategic partnerships with funders and partners to shape opportunities in the U.S...
$186.23k - $279.35k
Director, Regulatory Affairs Strategy - Cell Therapy Introduction to role Are you ready to steer global regulatory strategy for cell therapies that... ...will shape the regulatory path for programs that span oncology, immune‑mediated and rare diseases—translating breakthrough...Hourly payTemporary workLocal areaFlexible hours- BDO USA is looking for a Director of Business Development, Legal, Compliance & Risk in Maryland. This role involves driving sales performance... ...and work alongside practice leaders to improve sales strategies and initiatives. A Bachelor's Degree and five years of relevant...
- AstraZeneca is seeking a Director of Regulatory Affairs Strategy for cell therapy in the United States. The role focuses on shaping global regulatory strategy for CGT programs spanning oncology and immune-mediated diseases, translating breakthrough science into timely...
- Zenith LifeScience is seeking a Regulatory Affairs Director to provide strategic and operational regulatory leadership across the development, commercialization... ...regulatory lead on select programs and align regulatory strategy with clinical development and health authority...
- Merck & Co., Inc. in the United States is seeking an Executive Director to provide strategic direction for enterprise regulatory policy across regions and markets. The role requires senior expertise in regulatory processes, policy shaping, and actionable guidance for senior...
- Supernus Pharmaceuticals seeks a Director of Intellectual Property to lead the management, development, and protection of its patent and trademark portfolio. You will oversee US and worldwide filings, perform prior art searches, and coordinate with outside counsel for...Worldwide
- AstraZeneca in the United States is seeking a Director of Statistics to independently lead a biometrics team and deliver design, analysis, and interpretation for clinical programs and regulatory submissions. You will guide technical analyses, mentor staff, and collaborate...
- Overview The Executive Director, Enterprise Regulatory Policy Strategy provides strategic direction for our company's enterprise level regulatory policy approach across regions and markets. The ED will be a subject matter expert in regulatory processes, policies, laws,...For contractors
$157.5k - $262.5k
...development of and translating program strategies into cross-functional plans and ensuring... ...(e.g. pre‑clinical, manufacturing, regulatory, clinical, safety, data management) to... ...medicines which address unmet patient needs in oncology, infectious diseases and autoimmune...Temporary workWork experience placement$120.05k - $171.07k
...Program Manager plays a key role in translating the organization’s strategy into tangible results. This position partners with senior... ...standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure...Full timeWork at officeWorldwide- Merck is seeking an Executive Director, Enterprise Regulatory Policy Strategy to drive enterprise policy direction across regions. The role requires senior engagement with health authorities, multi-regional oversight, and leadership of policy initiatives aligned with R&...
- VariQ in Rockville, Maryland is seeking a highly qualified Proposal Manager who will oversee proposal activities and manage proposal schedules and deadlines. The ideal candidate should have leadership skills and experience in government contracting. The role requires 5+...Remote job
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director of Regulatory Strategy - NDA & Oncology. Be the first to apply!
- director global regulatory affairs Rockville, MD
- compliance program manager Rockville, MD
- regulatory affairs manager pharmaceutical Rockville, MD
- regulatory manager Rockville, MD
- manager regulatory affairs Rockville, MD
- regulatory & compliance manager Rockville, MD
- head compliance Rockville, MD
- regulatory affairs director Rockville, MD
- compliance director Rockville, MD
- compliance manager Rockville, MD


