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
$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...SuggestedHourly payTemporary work3 days per week- ...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
- ...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...SuggestedLocal area
$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$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,...SuggestedFull timeWork at officeLocal areaWorldwideNight shift$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...$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 payTemporary work3 days per week$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...$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 payTemporary work3 days per week- ...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...
- ...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...
$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- ...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 areaWorldwide
- ...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...
$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 payTemporary work- ...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...
$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 payTemporary workWorldwide3 days per week$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 payTemporary work3 days per week- ...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
- ...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
- ...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 payContract workTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week
$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 payTemporary workWork at officeFlexible hours3 days per week- ...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...
$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- 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...
- ...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 payTemporary workWork at officeLocal areaFlexible hours3 days per week
- ...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...
$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...- ...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
- ...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,...
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