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

Global CMC Regulatory Director

EmergencyMD

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 within the biotech/pharma sector. This role involves leading FDA meetings, ensuring timely submissions, and collaborating with project teams to achieve corporate goals. Strong communication and project management skills are essential. Attractive compensation package offered. #J-18808-Ljbffr

Vacancy posted 7 hours ago
Similar jobs that could be interesting for youBased on the Global CMC Regulatory Director in Gaithersburg, MD vacancy
  • $186.23k - $279.35k

     ...Are you ready to steer global CMC strategy for cell and gene therapies that redefine what’s possible for patients? This role positions you at the center of breakthrough programs, where your regulatory leadership translates pioneering science into high-quality submissions... 
    Suggested
    Hourly pay
    Temporary work
    3 days per week

    AstraZeneca

    Gaithersburg, MD
    4 days ago
  •  ...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... 
    Suggested

    AstraZeneca

    Gaithersburg, MD
    7 hours ago
  •  ...CMC Director/Senior Director, Regulatory Affairs Altimmune (NASDAQ: ALT) is a clinical stage biopharmaceutical company focused on developing treatments...  ...: This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle... 
    Suggested
    Local area

    Altimmune, Inc.

    Gaithersburg, MD
    3 days ago
  • $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... 
    Suggested

    AstraZeneca

    Gaithersburg, MD
    7 hours ago
  • $157.5k - $262.5k

     ...The Director of Regulatory Affairs will be responsible for assigned projects and all of the regulatory...  ...will also involve interacting with our global sites, both in-house and outsourced....  ...review of clinical trial labelling and CMC submissions for regulatory compliance,... 
    Suggested
    Full time
    Work at office
    Local area
    Worldwide
    Night shift

    American Society of Clinical Oncology

    Gaithersburg, MD
    8 hours ago
  • $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... 

    Initial Therapeutics, Inc.

    Rockville, MD
    7 hours ago
  • $178.53k - $267.8k

     ...Would you like to apply your Regulatory Affairs strategy expertise and...  .... The Regulatory Affairs Director (RAD) provides strategic and...  ...oncology products. Serves as the global regulatory lead (GRL) on early...  ..., emerging markets, RA CMC, Labeling and members of the... 
    Hourly pay
    Temporary work
    3 days per week

    AstraZeneca

    Gaithersburg, MD
    7 hours ago
  • $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... 

    AstraZeneca

    Gaithersburg, MD
    1 day ago
  • $178.53k - $267.8k

     ...Would you like to apply your Regulatory Affairs strategy expertise and...  .... The Regulatory Affairs Director (RAD) provides strategic and...  ...oncology products. Serves as the global regulatory lead (GRL) on early...  ..., emerging markets, RA CMC, Labeling and members of the... 
    Hourly pay
    Temporary work
    3 days per week

    AstraZeneca GmbH

    Gaithersburg, MD
    4 days ago
  •  ...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 for... 

    Green Key Resources

    Rockville, MD
    1 day ago
  •  ...Overview Do you have experience in all aspects of a Regulatory Affairs project, supporting technical/CMC, clinical, nonclinical and procedural aspects of strategy...  ...and maintain current licenses? As part of the Global Regulatory Affairs (GRA) team you will support and have... 

    GlaxoSmithKline

    Rockville, MD
    4 days ago
  • $222k - $370k

     ...Ensure the development of appropriate regulatory strategies and execution for assigned asset...  ...Responsibilities Accountable to the Global Regulatory Strategy TG Head and/or Portfolio...  ...in complex matrix teams with clinical, CMC, commercial, and safety functions. ~ Strong... 
    Local area

    GlaxoSmithKline

    Rockville, MD
    1 day ago
  •  ...Job Description Are you a subject matter expert in technical / CMC and procedural aspects of Global Regulatory Affairs, driven to provide in-depth input into asset specific regulatory strategy on a global scale for clinical/labelling or technical/NC or procedural... 
    Local area
    Worldwide

    GlaxoSmithKline

    Rockville, MD
    3 days ago
  •  ...sciences, ideally with a PhD and proven leadership in scientific organizations. ATCC offers a mission-focused environment supporting global health, with a range of benefits including comprehensive medical coverage and career advancement opportunities. #J-18808-Ljbffr... 

    Jobleads-US

    Gaithersburg, MD
    7 hours ago
  • $276k - $414k

     ...Within Oncology Regulatory Affairs, we work in areas of unmet need and take innovative regulatory approaches to bring...  ...seeking new treatments. The Executive Regulatory Science Director is a role that provides global strategic regulatory expertise and oversight to... 
    Hourly pay
    Temporary work

    AstraZeneca

    Gaithersburg, MD
    6 hours ago
  •  ...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... 

    AstraZeneca

    Gaithersburg, MD
    1 day ago
  • $186.23k - $279.35k

     ...passionate about scienceandexperienced within regulatory affairs and drug development? Do you...  ...affairsto get involved in the global regulatory strategies and support the research...  ...in the business. The Regulatory Affairs Director (RAD) provides strategic and operational... 
    Hourly pay
    Temporary work
    Worldwide
    3 days per week

    AstraZeneca

    Gaithersburg, MD
    1 day ago
  • $211.58k - $317.37k

     ...pandemic, we played an important role as part of a truly global effort to respond to a new and unprecedented challenge. We...  ...millions more people. Role The Senior Regulatory Affairs Director (SRAD) leads the global regulatory strategy for complex products... 
    Hourly pay
    Temporary work
    3 days per week

    AstraZeneca

    Gaithersburg, MD
    1 day ago
  •  ...A leading construction brand is seeking a Director, Legal to serve as the sole in-house legal advisor. This role involves overseeing legal...  ...legal risks while supporting business growth. Remote work with required global travel is part of the position. #J-18808-Ljbffr... 
    Remote work

    LATICRETE

    Derwood, MD
    1 day ago
  •  ...visit us at Follow LinkedIn, Facebook, Instagram, X and YouTube. Job Description Lead AbbVie\'s global Regulatory Policy & Intelligence function, overseeing Senior Director and Director-level leaders. Set strategic direction, drive organizational awareness and... 
    Worldwide

    Allergan

    Rockville, MD
    1 day ago
  •  ...clear value cases, adoption targets, and an investment roadmap. Global Standards and Transformation: Set global standards for...  ...effective human-in-the-loop oversight; ensure privacy, security, and regulatory alignment across markets. Use Case to Product Delivery:... 
    Hourly pay
    Contract work
    Temporary work
    Work at office
    Local area
    Worldwide
    Flexible hours
    3 days per week

    AstraZeneca

    Gaithersburg, MD
    1 day ago
  • $133.04k - $199.56k

     ...Job Title: Clinical Regulatory Writer, Associate Director / Manager Location: Gaithesrburg, MD- Hybrid (3 days onsite) Introduction to role: Are you...  ...move with agility, working seamlessly across functions globally. Our team is empowered to make quick decisions, influencing... 
    Hourly pay
    Temporary work
    Work at office
    Flexible hours
    3 days per week

    AstraZeneca

    Gaithersburg, MD
    7 hours ago
  •  ...planning, preparation, and submission of regulatory dossiers including but not limited to INDs...  ...degree with 5+ years) of experience in CMC regulatory affairs. Experience in manufacturing...  ...validations. Experience in working with global CMOs and CROs. Ability to interpret a... 

    Green Key Resources

    Gaithersburg, MD
    1 day ago
  • $138.75k - $231.25k

    Global Regulatory Affairs Manager - GSK As a Global Regulatory Affairs Manager at GSK, you will develop and execute global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance with internal and external... 
    Local area

    GSK

    Rockville, MD
    4 days ago
  • A leading biopharmaceutical company in Gaithersburg, 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... 

    Altimmune, Inc.

    Gaithersburg, MD
    2 days ago
  •  ...medical capabilities and elevates MSL excellence? As the Executive Director, you will report to the Vice President of Medical Excellence,...  ...for portfolio and Field Medical engagement. Collaborate with Global, Regional, and Country Medical teams, as well as R&D, Commercial... 
    Hourly pay
    Temporary work
    Work at office
    Local area
    Flexible hours
    3 days per week

    AstraZeneca

    Gaithersburg, MD
    4 days ago
  •  ...AstraZeneca is seeking a Global Marketing Associate Director in Gaithersburg, MD, who will be responsible for leading the development of strategic marketing initiatives for lung cancer. The candidate will engage with cross-functional teams and manage agency relationships... 

    AstraZeneca

    Gaithersburg, MD
    7 hours ago
  • $280.9k - $421.34k

    AstraZeneca is seeking a Global Safety Program Lead, Senior Director in Gaithersburg, MD. This role is accountable for the safety strategy and oversight of assigned assets, working closely with safety physicians and scientists to deliver high-quality safety content. The... 

    AstraZeneca

    Gaithersburg, MD
    2 days ago
  •  ...QIAGEN Regulatory Affairs Leader Opportunity At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible...  ...for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With... 
    Local area

    QIAGEN

    Germantown, MD
    3 days ago
  •  ...company in Maryland is seeking a Senior Director for Clinical Quality Assurance. This role...  ...that all clinical trials comply with regulatory expectations and quality standards. The...  ...successful candidate will lead the company's global Good Clinical Practice quality program,... 

    EmergencyMD

    Gaithersburg, MD
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global CMC Regulatory Director. Be the first to apply!