Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Manager, Global Regulatory Affairs, Oncology

$138.75k - $231.25k

GlaxoSmithKline

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

Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Manager, Global Regulatory Affairs, Oncology in Collegeville, PA vacancy
  • $138.6k - $231k

     ...are seeking a talented individual with Regulatory Affairs knowledge/experience and interpersonal...  ...Respiratory, Immunology & Inflammation (RII) Global Regulatory Strategy team. As a valued...  ..., immunology and inflammation; oncology; HIV; and infectious diseases - to impact... 
    Suggested
    Local area
    2 days per week
    3 days per week

    GlaxoSmithKline

    Collegeville, PA
    4 days ago
  •  ...Global Sr GRC Analyst Location: King Of Prussia, PA, US, 19406 Workplace Environment: Onsite Company...  ...that the organization operates within its regulatory, legal, and compliance obligations while managing risk effectively. The Global GRC Senior Analyst will... 
    Suggested
    For contractors

    UGI

    King of Prussia, PA
    3 days ago
  • $186.6k - $280k

     ...Summary: As Bioprocessing and Purification Technologies (BPT) Global Planning and Logistics Senior Director, you will spearhead end to...  ...transport, rail, and specialized chemical warehousing. * Manage relationships with 3PL/4PL providers, freight forwarders, and customs... 
    Suggested
    Hourly pay
    Minimum wage
    Local area

    Ecolab

    King of Prussia, PA
    4 days ago
  • $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... 
    Suggested
    Full time
    Contract work
    Temporary work
    Work experience placement
    Work at office
    Remote work
    Relocation
    Flexible hours
    Shift work
    3 days per week

    Lockheed Martin Corporation

    King of Prussia, PA
    3 days ago
  •  ...Quality operations in clinical and commercial development. This senior role involves strategic oversight of the Quality Management System, regulatory compliance, and fostering a cohesive Quality team. Candidates should have a Bachelor of Science and significant experience... 
    Suggested

    Harmony Biosciences

    Plymouth Meeting, PA
    4 days ago
  • A supply chain management firm is seeking an experienced Supply Chain Manager to oversee strategy and execution, including procurement, inventory control, and global logistics. The ideal candidate has a Bachelor's degree in Supply Chain Management and 5-7 years of relevant... 

    McCloskey Partners, LLC

    Telford, PA
    4 days ago
  • Merck & Co. is seeking a Director, Global Clinical Supply Planning responsible for managing the planning, execution, and delivery of clinical trial supplies....  ...leadership and communication skills, ensuring adherence to regulatory requirements and fostering a culture of continuous... 

    Merck & Co.

    West Point, PA
    5 days ago
  • CSL Plasma Inc. is seeking a Senior Director, HRBP, based in King of Prussia. This role involves leading global HR initiatives and collaborating with senior leadership to implement HR strategies that drive business success. Candidates should have 12-15 years of HR experience... 

    CSL Plasma Inc.

    King of Prussia, PA
    4 days ago
  • Overview The Global Clinical Supply (GCS) organization is accountable for managing the ‘end-to-end’ integrated clinical supply chain across the full portfolio of our...  ...Trial Operations (GCTO), Development, Quality, Regulatory, Technical Operations, and external vendors to... 
    For contractors
    Work at office
    Local area

    Merck & Co.

    West Point, PA
    5 days ago
  •  ...Description Client: Direct Client Location: Wayne, PA Job Title: Regulatory Affairs Manager Duration: 6 Months+ Job Summary Responsible for managing...  ...with FDA and coordinate with regulatory management and global regulatory leads. Represent US regulatory strategy in product... 

    Integrated Resources Inc.

    Wayne, PA
    4 days ago
  • $173.2k - $272.6k

    Job Overview The Global Clinical Supply (GCS) organization is accountable for managing the end‑to‑end integrated clinical supply chain across our Research & Development...  ...partner organizations (clinical development, regulatory, quality, and other supply chain areas) to... 

    Merck & Co.

    West Point, PA
    5 days ago
  • CLA (CliftonLarsonAllen) in King of Prussia is looking for a Manager/Director - Transfer Pricing to join their International Tax Services team. This role includes managing transfer pricing planning and compliance, training associates, and providing financial modeling. Required... 
    Flexible hours

    CLA (CliftonLarsonAllen)

    King of Prussia, PA
    2 days ago
  •  ...and acquisitions, joint ventures, minority investments, and other strategic transactions across SEI’s global organization. This attorney will report to the Managing Director - Corporate Governance, M&A and Strategic Transactions attorney. Primary Duties and Responsibilities... 
    Flexible hours
    Shift work

    SEI Investments Company

    Oaks, PA
    5 days ago
  •  ...process, ensuring compliance with legal and regulatory standards, and collaborating across...  ...industry and a strong background in Medical Affairs. The position offers a full-time...  ...innovation and continuous improvement in grants management. #J-18808-Ljbffr CSL Plasma Inc.
    Full time

    CSL Plasma Inc.

    King of Prussia, PA
    2 days ago
  •  ...budgeting, execution tracking, and performance management. The role ensures that medical...  ...requirements, therapeutic area priorities, and Global and Commercial where needed. Support...  ..., and best practices across Medical Affairs operations, while identifying, sharing across... 
    Work at office
    Local area
    Remote work

    National Society for Black Engineers

    Collegeville, PA
    5 days ago
  •  ...provide expertise in Antibody Drug Conjugates (ADCs) and support the implementation of quality management systems, ensuring compliant supply of specialty products globally. Key responsibilities include quality oversight, trend reporting, and collaboration across teams... 

    Merck & Co.

    North Wales, PA
    5 days ago
  • $8k

    Senior Quality and Regulatory Manager Colorcon® is a world leader in the development, supply and...  ...supply from multiple locations, with our Global Headquarters located in Harleysville,...  ...Head - Innovation, Quality and Regulatory Affairs. Responsibilities & Duties Lead site... 
    Remote work
    Work from home
    Home office

    Colorcon, Inc.

    North Wales, PA
    5 days ago
  • A leading staffing firm is seeking a Regulatory Affairs Manager for a 6-month contract in Wayne, PA. The role involves managing regulatory activities in line with US requirements, ensuring compliance, and coordinating submissions for products. Ideal candidates will have... 
    Contract work

    Integrated Resources Inc.

    Wayne, PA
    3 days ago
  • iPipeline, located in Wayne, Pennsylvania, is seeking a Director of Customer Success to lead a team of Customer Success Managers. This role involves driving customer adoption, expansion, and retention strategies across a portfolio of strategic customers. The ideal candidate... 
    Flexible hours

    iPipeline

    Wayne, PA
    2 days ago
  •  ...analytical and problem solving skills Involved in testing web services using JSON requests with Postman SoapUI Experience with test management tools JIRA Advanced knowledge of common software testing procedures and methodologies Familiar with new innovative trends... 
    Contract work

    Staffing the Universe

    Mont Clare, PA
    2 days ago
  •  ...agreements, risk based monitoring, issue management, and continuous improvement—ensuring...  ...to audit management as well as industry/regulatory trends in this area. Identify and/or...  ...About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise... 
    Remote work

    CSL

    King of Prussia, PA
    4 days ago
  •  ...documentation to the standard required Ensure the system data integrity by maintaining those functions necessary for daily operations. Managing defects: raising defects, ensuring that all relevant information is logged; reporting and progression through to resolution CI/... 
    Work experience placement

    Software Technology Inc

    Mont Clare, PA
    4 days ago
  • A leading supplier in the pharmaceutical industry is seeking a Supply Chain Manager in West Point, PA. The role involves managing supplier risk, strategic sourcing, and ensuring supply continuity. Candidates should possess a Bachelor's degree in Supply Chain Management... 
    Flexible hours

    Colorcon®

    West Point, PA
    4 days ago
  •  ...Director of Mergers & Acquisitions to join its Legal and Compliance Department in Oaks, Pennsylvania. This mid-level attorney will manage strategic transactions, ensuring effective legal support for SEI's growth initiatives. The ideal candidate will possess a Juris Doctor... 

    SEI Investments Company

    Oaks, PA
    5 days ago
  • $8k

     ...quality, unparalleled technical support, extensive regulatory assistance and reliable supply from multiple locations, with our Global Headquarters located in Harleysville,...  ...continuity of supply and total cost of ownership. Manage and develop supplier relationships, serving... 
    Work at office
    Remote work
    Work from home
    Home office
    Flexible hours

    Colorcon®

    West Point, PA
    3 days ago
  • $110k - $160k

     ...domestically to meet client project requests. The Maintenance Planning Manager is responsible for leading the development and implementation...  ...timelines and quality expectations. Support coordination with Global Facilities Delivery (GFD) or equivalent engineering... 
    Full time
    Work visa

    PerkinElmer

    Mont Clare, PA
    a month ago
  •  ...to oversee the onboarding of investors and ensure compliance with regulations. This role involves generating investor reporting, managing client communications, and facilitating daily wire activities. Candidates should have a BA in relevant fields and 2+ years in fund... 

    SEI

    Oaks, PA
    5 days ago
  •  ...role in maturing cybersecurity function toward proactive risk management capabilities. Key Responsibilities Provide analytic expertise...  ...outside teams to effectively manage IT security framework and regulatory requirements Support incident response and trouble... 
    Remote work

    Software Technology Inc

    Conshohocken, PA
    4 days ago
  •  ...SERM Scientific Director to oversee pharmacovigilance and risk management within clinical development. The ideal candidate will have a...  ...pharmaceutical or biotech industry. They will lead safety components of regulatory submissions and work cross-functionally to enhance drug safety... 

    Women In Bio

    Collegeville, PA
    2 days ago
  • A global biotech company in King of Prussia is seeking a Director for PEO Partner Management. This role focuses on leading strategic IT partner management and ensuring alignment with business objectives while driving improvement and delivering value. Candidates should... 

    CSL

    King of Prussia, PA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Manager, Global Regulatory Affairs, Oncology. Be the first to apply!