Global Regulatory Submissions Team Lead
Novartis AG
Novartis AG is seeking a CTA/CTR Team Lead to guide a global regulatory team in delivering high-quality clinical trial submissions and approvals. You will combine people leadership with regulatory expertise to drive smarter, compliant processes across functions and geographies. You will shape regulatory strategy, coach team members, and build strong partnerships with stakeholders, while championing continuous improvement, automation, and an agile way of working within the organisation. #J-18808-Ljbffr Novartis AG
- ...accessible. Job Description Shape how global clinical trials move forward. As CTA/CTR Team Lead, you'll lead and develop a global regulatory team responsible for delivering high-... ..., compliant and timely clinical trial submissions and approvals. You'll combine people leadership...RegulatoryWork at officeLocal areaRemote workRelocation packageFlexible hours
- ...organization provides regulatory expertise related to CMC... ...organization develop global regulatory CMC... ...business priorities. The team also performs regulatory... ...Health Authority submissions. The team also supports... ...including participating / leading HA meetings with...RegulatoryFull time
$263.25k
...to "be an innovative global healthcare company contributing... ...trial portfolio and submissions are delivered to time,... ..., and cost. The teams reporting into this role... ..., clinical sciences, regulatory, biostats, data... ...Proven experience in leading and implementing improvement...RegulatoryWork experience placement- A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing... ..., and collaboration with product teams to ensure high-quality deliverables. Ideal...Regulatory
- Sarepta Therapeutics is seeking a Regulatory Affairs Lead to guide clinical trial activities, review CRO submissions, and support regulatory strategy across markets. This US... ...requires collaboration with cross-functional teams and a strong emphasis on timely, compliant submissions...RegulatoryRemote job
- Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for the Restorative Healing Technologies portfolio. Remote... ...travel up to 10%. You will guide regulatory strategy, submissions, and lifecycle compliance across multiple regions. The...RegulatoryRemote job
- LEO Pharma is seeking a Senior Specialist, Regulatory Affairs - Promotional Review to edit Legal, Medical... ...brands and new products. You will manage submissions and ensure quality control across marketing materials. Join a global medical dermatology leader with a commitment...Regulatory
- Job-ID29499131Reference26-29348Scientific - Global Regulatory CMC Manager EEO: “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”Regulatory
- ...consumer & ECP big idea, and lead concept, claims, key... ...the candidate has global experience as well as innovation... ...Safety Management Team.5. Serves as safety... ...responses to inquiries from regulatory authorities or health... ...active development, submission phase and during marketing...RegulatoryWork at officeImmediate start
$144.16k - $216.24k
...difference, there’s only one choice.Global Consolidated Customer Data & AI Lead The Global Consolidated Customer... ...global scale, while ensuring business teams can act on high-quality and... ..., licensing terms, and applicable regulatory requirements in partnership with Legal...RegulatoryLocal area$225k - $260k
...behind everything we do. As a global leader with the most comprehensive... ...becoming part of a passionate team that knows every moment... ...Leader, Advanced Staining Reagents leads scientific aspects of global... ...Digital Pathology, R&D, Clinical, Regulatory, Commercial, Sales and...RegulatoryFull timeRemote workWork from homeFlexible hours- A leading pharmaceutical firm in New Jersey is seeking a Regulatory Affairs Associate I to manage low- to medium-impact regulatory submission projects. You will be responsible for coordinating submission... ...with cross-functional teams. The ideal candidate has a Bachelor...RegulatoryContract work
- ...Global Transplant Medical Lead, SOT At Sanofi, we chase the miracles of science. In Transplant Medicine... ...'s most complex frontiers, and our team is committed to advancing it. We are... ...partnerships with R&D, Commercial, Regulatory Affairs, and Legal teams to ensure integrated...RegulatoryWorldwide
$157k - $210k
...platform of technology, tools, and teams that enables innovators to build and... ...AI with confidence. Trusted by leading AI labs, startups, and global enterprises, CoreWeave combines superior... ...advise the business on legal and regulatory issues that directly impact CoreWeave...RegulatoryPermanent employmentFull timeContract workTemporary workCasual workWork at officeLocal areaFlexible hours$193.04k - $289.56k
...vision to "be an innovative global healthcare company contributing... ....Job SummaryThe Global Regulatory Lead (GRL) is responsible for leading... ...peers and cross-functional team members regarding strategic... ...books, and health authority submission documents.Serves as the primary...Regulatory- ...Coast location, requiring recent submissions writing experience and... ...senior medical writer, you will lead the preparation of English-language... ...clinical documents and regulatory dossiers, mentor junior writers... ...coordinate cross-functional teams to ensure timely, compliant...RegulatoryRemote job
- ...Executive Director, Global Medical Operations About the Company Internationally renowned... ...will have a deep understanding of regulatory and compliance standards, as well as the... ...Director will be a key member of the leadership team, representing global medical operations...RegulatoryLocal area
$249.1k - $327k
...from you.The Senior Director, Global Regulatory Affairs, Neurology will... ...objectives related to regulatory submissions and milestones, and clinical... ...Director is responsible for leading the activities of Regulatory... ...are clearly defined within teams, important information...RegulatoryFull timeTemporary workRemote work3 days per week- ...passion for lifeJoin our diverse teams of passionate people and a... ...location.Job OverviewThe Global Head of Regulatory Affairs, Surgical Workflows,... ...maintaining market access, leading regulatory remediation, overseeing regulatory submissions and registrations, and managing...RegulatoryRemote workWorldwide
- Job Description The Specialist Regional Submissions Planner will work within our Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional... ...through delivery to country regulatory affairs teams and/or Health Authorities. Develop and maintain the...RegulatoryFlexible hours
- ...operations, the company caters to its globally positioned clients by providing dynamic... ...core science summaries in support of Regulatory Submissions. Engage with external medical and scientific... ...complex projects with highly-matrixed teams Facilitate debate and conclusions to...Regulatory
$116k - $145k
...clinical and nonclinical regulatory strategic discussions,... ...activities at the team level to support assigned... ...regulatory affairs clinical lead for clinical trial... ...all regulatory agency submission materials for submissions... ...regulatory support to Global Regulatory Lead in definition...RegulatoryWork at officeRemote work- A prominent staffing firm is seeking a Regulatory Site Quality Specialist in Florham Park, NJ... ...regulatory tasks, and collaborating across teams. Key qualifications include a BS degree... ...work within a dynamic and challenging sector. #J-18808-Ljbffr Insight Global (United States)Regulatory
- OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America, including FDA activities for SaMD/SiMD and electromechanical devices. The role requires collaborating with Manufacturing, Quality, R&D, and Marketing to...RegulatoryRemote jobFlexible hours
- ...Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada is responsible... ...the Manager (Global Regulatory Lead (GRL), Associate Director, or Director... ...preparation and review of regulatory submissions consistent within US and Canada regulatory...RegulatoryWork at officeLocal areaRemote work
$127k - $168k
...platform of technology, tools, and teams that enables innovators to build and... ...AI with confidence. Trusted by leading AI labs, startups, and global enterprises, CoreWeave combines superior... ...equity.Monitor market trends and regulatory changes (e.g., pay transparency laws...RegulatoryPermanent employmentFull timeTemporary workCasual workWork at officeFlexible hours$140.3k - $192.94k
...International?Join our Mission to Lead the Future of Snacking. Make... ...lead of an expert nutrition team, inspiring and empowering them... ...in robust nutrition science, regulatory and policy foresight and evolving... ...across the country. Mondelēz Global LLC is an Equal Opportunity...RegulatoryFull timeWork at officeRemote workRelocation package3 days per week- ...Description• Assist and support regulatory CMC managers in the following activities:• Defining global CMC regulatory strategy and... ...marketed products to achieve optimal submission/approval results and ensure... ...life cycle, to project teams and appropriate management levels...RegulatoryImmediate start
- ...Inc. seeks a Sr. Medical Writer to support the development of global regulatory documentation strategy and the execution of tactics. You... ...requires a strong background in medical writing, regulatory submissions, and project management, with 6-8 years of industry experience...RegulatoryRemote job
- ...Description The Risk Management Lead (RML) serves as the subject... ...risk management practices across global clinical trials, partnering closely with study teams and Central Monitoring colleagues... ...high-quality study execution and regulatory compliance. Key...RegulatoryFull timeLocal area3 days per week
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