Director, Global Regulatory Affairs - Biologics
Immunocore Limited
Immunocore is seeking a Director of Regulatory Affairs to lead the Tactical Implementation team, overseeing US and EU submissions, IND/CTA planning, and regulatory intelligence across global programs. This role drives strategy, mentoring, and cross-functional collaboration in a fast-paced biologics environment. You will coordinate submissions, liaise with health authorities, manage resources, and ensure compliance while developing a high-performing team with worldwide regulatory experience. #J-18808-Ljbffr
- Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions... ...filings. The successful candidate will bring a strong biologics background, strategic leadership, and the ability to...SuggestedRemote job
$166.65k - $277.75k
...Regulatory DirectorEnsure the development of appropriate... ...of an overall global regulatory approach and... ...plans. The Regulatory Director may be the single point... ...Qualifications:Bachelor's degree: Biological or Healthcare Science5... ...industry regulatory affairs experience5 or more...SuggestedTemporary workLocal area$189.5k - $235k
Vacancy Name Director, Regulatory Affairs-Global Regulatory Lead Vacancy No VN723 Employment Type Full Time Location of role Gaithersburg, MD, Radnor... .... The ideal candidate will have experience gained in biologics and the preparation of late-stage regulatory fillings, with...SuggestedFull timeWork at officeLocal areaRemote workWorldwideNight shift$171.6k - $286k
...are seeking an experienced regulatory leader to join our Global Regulatory Strategy... ...professional experience in biological science, healthcare science... .... Significant regulatory-affairs experience across pharmaceutical... ..., Regional Regulatory Director or in a comparable...SuggestedWork at officeLocal areaRemote work$208.06k - $262.15k
...fairness, integrity, and global collaboration. This... ...scientific integrity, regulatory excellence, and evidence... ...and/or biologics(GxPs).Experience with/... ...followingdirect reports:Director / Sr Manager, International... ...504Job Category: Ext. Affairs, Regulatory, \& CommunicationsSchedule...SuggestedFull timeWork experience placementWork at officeWorldwide$250k - $300k
...entrepreneurial roots to our current global presence, we've grown into a force for... ...and together, let's shape the future of biological discovery. About the opportunity... ...is a senior global leadership role in Regulatory Affairs responsible for defining and executing...Full timeLocal areaWorldwide$160k - $218k
Rockville, Maryland / RemoteOperations - Regulatory /Full Time /HybridSince our... .... The opportunityAs Associate Director, Regulatory Affairs, you'll lead global regulatory strategy for a therapeutic... ...'s degree; an advanced degree in biological sciences is preferred.• 6-8 years...Full timeWork experience placementSummer workLocal area- Autolus Inc. is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead global labeling and promotion strategy, ensuring compliance across the US/UK/EU. You will partner with Commercial, Medical, Legal, and Compliance teams to deliver compliant...
$195.47k - $293.2k
Director, Global Insights & Forecasting, Early Assets & Business Development (R&I)You will play a pivotal role in guiding critical investment... ...agility to quickly assess new indications, modalities, and biological targets.Solid understanding of commercial drivers, market...Full timeTemporary workWorldwideShift work- ...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...
- ...AstraZeneca GmbH in the United States is seeking a Senior Regulatory Affairs Director to lead global regulatory strategy for complex products, driving rapid approvals and advantageous labeling. You will chair the Global Regulatory Sub-team with regional input, manage...
$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 redefine standards of care for... ...standing experience of overall drug/biologic development processes and strategies...Hourly payTemporary workLocal areaFlexible hours- GSK seeks an experienced Director of Global Regulatory Strategy to lead regulatory planning for Respiratory, Immunology and Inflammation assets. You will shape development programmes, coordinate with global teams and drive regulatory submissions with health authorities...
- ...Gaithersburg, MD, Radnor, PA Department Regulatory Affairs The Director of Regulatory Affairs will be... ...making project assignments with the Global Regulatory Leads and VP of Regulatory... ...candidate will have experience gained in biologics and the preparation of early and...Worldwide
- ...AstraZeneca plc in Gaithersburg is seeking a Senior Director for Global Regulatory Digital Strategy. You will lead the development and implementation of a comprehensive digital strategy across Regulatory, working with IT, AI units and external partners to ensure delivery...
- Green Key Resources is seeking a highly technical Regulatory Affairs Manager / Senior Manager in Gaithersburg, MD for a 100% hands-on CMC role... ..., manage regulatory strategy, and collaborate with global teams and CMOs/CROs. The ideal candidate has a Master’s or PhD...
- Role Senior Director of Regulatory Affairs overseeing global regulatory strategies for biologics development, with a focus on late-stage filings. Responsibilities lead IND, BLA, sBLA submissions develop regulatory scientific and tactical strategies liaise with FDA, EMA...
- ...Job Description Job Description The Senior Manager, Global Promotional Regulatory Affairs is responsible for providing regulatory leadership and guidance for promotional, medical, and other external communications while supporting the development and maintenance of...
- ...premier clinical research organization, seeks a Senior Director, Quality Assurance to lead the global QA program and support the VP of Quality & Compliance... ...improvement across worldwide trials, ensuring regulatory readiness and strong QMS governance. You will manage...Worldwide
- Vacancy Name Director, Global Market Access Strategy, RWE, HEOR and Pricing... ...work closely with Medical Affairs and other global functions... ..., Clinical Development, Regulatory, Biostats and Project Management... ...on delivering first‑class biological therapies to patients, we...Permanent employmentLocal areaFlexible hours
$212.99k - $319.44k
...Job Title: Senior Director Global Regulatory, Digital Location: Gaithersburg At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a...Hourly payTemporary workWork at officeWorldwide3 days per week- ...and experienced Senior Manager/Manager, Regulatory Affairs(level based on candidate experience).... ...responsible for knowledge and application of global regulations governing pharmaceutical... ...development of pharmaceuticals, biologics and medical devices.Experience in compilation...Work at office
- ...adoption targets, and an investment roadmap. Global Standards and Transformation: Set global... ...; ensure privacy, security, and regulatory alignment across markets. Use Case to Product... ...dynamic responsibility across Medical Affairs, Medical Excellence, Digital/IT, or Commercial...Hourly payFull timeContract workTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week
$126.25k - $171.58k
...commitment to fairness, integrity, and global collaboration. This belief is embedded... ...Job Overview The Senior International Regulatory Affairs Manager serves as a critical enabler of... ...areas include API quality; standards for biologics; new biologic / peptide treatments; appropriate...Full timeWork at officeWorldwide- ...Grumman is seeking an experienced Empowered Official to join the Global Trade team as Manager 2, Global Trade, leading a group of trade... ...controls. Based in Linthicum, MD, the position requires deep regulatory knowledge, strong leadership, and the ability to partner with cross...
- ...together we are ONE Autolus.Job Description:Role SummaryThe Director, Regulatory Affairs Advertising, Promotion & Labelling is responsible for... ...objectives. Serving as an internal subject matter expert on global labelling, Advertising & Promotion landscape, this role requires...Local areaFlexible hours
- The Oncology Global MSL Excellence Director is accountable for defining the oncology tumour-area specific Field Medical strategy and overseeing the... ...GMSLE Director collaborates closely with Global Medical Affairs, Global Clinical Operations, Global Medical Excellence,...Full timeLocal area
$162k - $225k
We are seeking an experienced Director of Global Privacy and Compliance to lead the design, implementation, and oversight of Precision Medicine... ...as appropriate with key PMG internal and external legal, regulatory, finance, and other business units as well as US based legal...Local area$162k - $225k
Director of Global Privacy and Compliance Bethesda, MD, USA We are seeking an experienced Director of Global Privacy and Compliance to lead... ...Liaising as appropriate with key PMG internal and external legal, regulatory, finance, and other business units as well as US based legal...Local area$113.85k - $189.75k
...Our approach to R&DRegulatory Affairs Manager, CMC mRNA Vx Development ProductsAs a Regulatory Affairs Manager in Chemistry, Manufacturing... ...to make a meaningful impact on global health while advancing your... ..., with exposure to vaccine or biologics development and regulatory...Full timeWork at officeLocal areaRemote work
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