Manager, Global Regulatory Affairs, Oncology
$138.75k - $231.25kGlaxoSmithKline
Location: USA – Pennsylvania (Upper Providence) – Durham Blackwell Street, USA – Maryland (Rockville), USA – Massachusetts (Waltham) Key Responsibilities Work closely with GRL, global/regional counterparts and local operating companies to develop and deliver robust regulatory strategies that meet key market requirements. Collaborate with cross-functional teams to align regulatory plans with Medicines Development Strategy and Integrated Asset Plan. Support interactions, reviews, and submissions with regional/local regulatory authorities for product development and approval. Assess regulatory intelligence, precedents and competitive landscape to inform strategy development and improve decision‑making. Ensure compliance with global, regional, and local regulatory requirements throughout the product lifecycle. Drive process improvement, innovation, and performance excellence through the development and implementation of strategic changes. Basic Qualifications & Skills Bachelor's degree in biological or healthcare science. 1+ years experience in the drug development process within regulatory affairs, preferably oncology. 1+ years of experience in clinical trial requirements in at least one major regional/global market. Preferred Qualifications & Skills Advanced Scientific Degree (PhD, MD, PharmD). Proven ability in managing global and regional development, submission, and approval activities. Demonstrated ability to foster collaborative environments, proactively resolve challenges, and develop innovative solutions within regulatory constraints. Proficiency in digital fluency tools to enhance project delivery, efficiency, and innovation. Strong written and verbal communication skills for clarity and impact. Experience working effectively in matrix teams. Annual base salary ranges from $138,750 to $231,250 based on location. The position offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr GlaxoSmithKline
$138.75k - $231.25k
Global Regulatory Affairs Manager Develop and execute global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance with internal and external requirements. Collaborate with cross‑functional teams to...SuggestedLocal area$222k - $370k
...the development of appropriate regulatory strategies and execution for... ...Accountable to the Global Regulatory Strategy TG Head and... ...Significant experience in regulatory affairs (10+ years) ~5 + years... ...Knowledge and experience in Oncology TA, preferably with ADC and lung...SuggestedLocal area- ...areas including immunology, oncology and neuroscience—and products... ...Description Lead AbbVie\'s global Regulatory Policy & Intelligence function... ...15+ years) in regulatory affairs, health authority, and/or policy... ...written), and stakeholder management skills. Experience...SuggestedWorldwide
- ...matter expert in technical / CMC and procedural aspects of Global Regulatory Affairs, driven to provide in-depth input into asset specific regulatory... ...received from the agencies? If so, this Vaccines Senior Manager of Global Regulatory Affairs role could be an ideal...SuggestedLocal areaWorldwide
- GlaxoSmithKline in Rockville is seeking a Regulatory Affairs professional to develop and implement regulatory strategies for product approvals... ...1 year of regulatory affairs experience, preferably in oncology. The role involves collaboration with various teams and ensuring...Suggested
- ...you have experience in all aspects of a Regulatory Affairs project, supporting technical/CMC,... ...maintain current licenses? As part of the Global Regulatory Affairs (GRA) team you will... ...for a challenge? If so, this Vaccines Manager of Global Regulatory Affairs role could...
$153.5k - $203.25k
Initial Therapeutics, Inc. is seeking an International Advocacy Director to advance medicine quality initiatives on a global scale. The successful candidate will shape regulations through key organizations such as the World Health Organization and engage in strategic advocacy...- ...in-house legal advisor. This role involves overseeing legal affairs, managing external counsel, and providing strategic legal guidance on corporate... ...legal risks while supporting business growth. Remote work with required global travel is part of the position. #J-18808-Ljbffr...Remote work
$178.53k - $267.8k
AstraZeneca GmbH is seeking a Regulatory Affairs Director in Gaithersburg, MD. In this role, you will provide strategic regulatory leadership for oncology products, leading cross-functional teams and managing regulatory submissions. With a strong focus on collaboration...- ...areas including immunology, oncology and neuroscience - and products... ...The Director, Regulatory Affairs, U.S. Regulatory Policy & Intelligence... ..., and interacts with senior management. Independently manages and... ...strategy that is developed by the Global Regulatory Leads and...Local area
- ...rare‑disease biopharmaceutical company is hiring a Senior Manager, Regulatory Affairs (CMC) to lead regulatory strategy and submissions for products... ...‑approval stages. This is a high‑impact role supporting global filings, CMC strategy, and Health Authority interactions...
$178.53k - $267.8k
...Regulatory Affairs Director Oncology R&D Gaithersburg, MD Hybrid Work- on average 3 days a week from office... ...commercialisation, and life cycle management of the assigned cell and gene... ...CGT) product(s). You'll serve as the global regulatory lead (GRL) on early-stage...Temporary workWork at officeFlexible hours3 days per week- AstraZeneca is seeking an Executive Regulatory Science Director in Gaithersburg, MD to provide global strategic regulatory expertise for oncology products. This leadership role involves mentoring regulatory leads, planning resources, and ensuring submission excellence while...
$72.6k - $106.8k
...Located Remotely? N Position Type Management Pay Range: $72,600-$106,800 annually... ...begin your purpose, belong to an amazing global team, and become the best version of you... ...management processes, ensures compliance with regulatory and ESG reporting requirements,...Full timeWork at officeRemote workFlexible hours3 days per week- ...Senior Manager, Regulatory Affairs Job Description: POSITION PURPOSE: This individual is expected to actively contribute to the development... ...testing, and validations. Experience in working with global CMOs and CROs Ability to interpret a variety of scientific...
$276k - $414k
Within Oncology Regulatory Affairs, we work in areas of unmet need and take innovative regulatory approaches... ...Director is a role that provides global strategic regulatory expertise and... ...regulatory environment and advise senior management on project risks/mitigation...Hourly payTemporary work$211.58k - $317.37k
AstraZeneca is seeking a Senior Regulatory Affairs Director to lead the global regulatory strategy for complex products. This role is crucial for securing rapid approvals in alignment with market and patient needs. The ideal candidate will have at least 10 years of regulatory...- A clinical-stage biopharmaceutical company is looking for an experienced regulatory CMC professional to manage submissions and oversee compliance with global regulatory guidelines. The ideal candidate will have a Ph.D. and significant experience in CMC lifecycle management...
- ...QIAGEN Regulatory Affairs Leader Opportunity At QIAGEN, we are driven by a simple but powerful... ...our entrepreneurial roots to our current global presence, we've grown into a force for... ...goals to meet business objectives. Manage the annual global regulatory affairs operating...Local area
- ...Join AstraZeneca's Oncology Business Unit (OBU) in a role where strategy meets scientific... ...consulting in which you have contributed to the global pipeline strategy e.g. market assessment,... ...decisive and proactive; must be able to manage multiple priorities in a fast-growing...Hourly payTemporary work
$270.22k - $405.33k
...At AstraZeneca, our Oncology ambition is unparalleled. We'... ...you will own and drive the global Oncology R&D strategy, setting... ...design, competitive dynamics, regulatory environments, and market access... ...finance experience: Background in management consulting, venture capital,...Temporary workWork at officeFlexible hours3 days per week$53.07 - $78.55 per hour
...Number 26058096 Job Category Revenue Management Location 7750 Wisconsin Ave,... ...solutions, working in close partnership with Global Technology, Product, and cross-functional... ...with applicable policies, procedures, and regulatory requirements related to system...Hourly payFull timeRemote workFlexible hoursNight shiftWeekend work- ...Director of Business Development to drive revenue growth in Hematology and Oncology. This high-impact role involves securing new sponsor relationships, developing strategies for clinical studies, and managing complex sales cycles. The ideal candidate will have a bachelor's...Remote jobFlexible hours
- ...Director to advance medicine quality initiatives with international organizations. This role focuses on developing and executing regulatory policy advocacy strategies, engaging with stakeholders, and promoting quality in medicines worldwide. The ideal candidate will have...Worldwide
$103.7k - $179.86k
...and Compliance Lead will report to the Global Medical Services (GMS) Business Operations... ...with Lockheed Martin’s expectations and regulatory requirements. The ideal... ...excellent communication skills, experience managing large-scale projects, and ability to deliver...Full timeContract workTemporary workWork experience placementWork at officeRemote workRelocationFlexible hoursShift work3 days per week$170k - $200k
...business activities within a well-controlled regulatory environment, consistent with ISS STOXX... ...standards. The CCO reports to the Global Chief Compliance Officer of ISS STOXX, as... ..., authority, and access to senior management consistent with regulatory expectations...Local areaWorldwideFlexible hours- Are you passionate about Regulatory Writing? Would you like to have an... ...is the home of R&D and Oncology in the US. Here, we play host... ...is expected to: Independently manage clinical regulatory writing activities... ...form. AstraZeneca is a global, science-led, patient-focused...Hourly payFull timeTemporary workWork at office
- ...strategy for our industry-leading oncology pipeline. Collaborate with R&... ...with Oncology R&D and global franchise partners. Engage... ...and proactive; must be able to manage multiple priorities in a fast... ...Thorough understanding of regulatory and pricing dynamics in major...Hourly payTemporary work
- ...Maryland, is seeking a Senior Director of Clinical Quality Assurance to lead its global quality program for clinical trials. The role includes overseeing compliance with GCP standards, managing quality audits, and spearheading the CQA function. Ideal candidates have at...
- Capital One is seeking a Business Analysis Manager in McLean, VA to drive strategic initiatives within their Global Payment Network. The role involves developing growth strategies, supporting business development, and leading analysts. Candidates should bring at least...
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