Regulatory CMC Director - Strategic Global Submissions Lead
Dormont Manufacturing Company
Neurocrine Biosciences is seeking a Regulatory Affairs Leader responsible for overseeing Regulatory CMC for commercial products. Ideal candidates should have extensive experience in regulatory affairs, excellent leadership skills, and the ability to guide cross-functional teams through the regulatory process. This role is vital to ensure compliance with marketing applications and involves strategic oversight of regulatory submissions. A strong background in FDA and EMA regulations is essential, along with a passion for impactful science. #J-18808-Ljbffr
$132.7k - $182k
...Neurocrine Biosciences is seeking a CMC Regulatory Affairs Manager in San Diego, California. This role involves overseeing regulatory activities for development and marketed projects, managing submissions, and ensuring compliance with government regulations. The ideal...Suggested- ...Therapeutics is seeking an experienced leader in Regulatory Operations based in San Diego, California. The candidate will oversee global regulatory submissions and optimize regulatory systems/tools. Responsibilities include leading regulatory operations, ensuring compliance...Suggested
$180k - $210k
...A leading nonprofit research institute in San Diego seeks a Director of Regulatory Affairs to guide regulatory strategies and management of submissions. Candidates should have over 12... ...interactions with global health authorities... ..., and developing strategic plans to support...Suggested$187.9k - $256k
...Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical... ...Role: Responsible for the strategic Regulatory CMC leadership for assigned... ...of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient... ...strategic guidance on global regulatory CMC requirements...SuggestedContract work$228k - $245k
...Overview The Director, Global Regulatory Affairs will play a critical... ...programs. Be the regulatory lead for project teams and... ...the preparation, submission, and maintenance of... ...Therapeutic Discovery, and CMC teams. Monitor and... ...and to inform strategic planning. Manage regulatory...SuggestedFull timeSummer workWork at officeRemote workRelocation packageMonday to Friday$240k - $275k
...The Senior Director, Global Regulatory Affairs will provide strategic regulatory leadership across Janux... .... This individual will lead global regulatory strategy... ...including Clinical, CMC, Biometrics, and Translational... ...(CTR) and CTA submissions. Serve as the primary...Full timeSummer workWork at officeRemote workRelocation packageMonday to FridayShift work$150k - $194k
...A biopharmaceutical company in San Diego seeks an Associate Director, Regulatory Affairs CMC. This role focuses on regulatory strategy execution for drug development. You will oversee regulatory submissions, maintain director-level interactions, and manage project timelines...Remote work- ...CorDx in San Diego, California is seeking an Associate Regulatory Affairs Manager to support regulatory document submissions for medical devices and IVD products. The ideal candidate will have a master's degree and 4-6 years of relevant experience, including 510(k) submissions...
$150k - $194k
...Associate Director, Regulatory Affairs CMC page is loaded## Associate Director, Regulatory... ...rigorous innovation can lead to better lives. Our work... ...and prepare regulatory submissions (authoring, timeline planning... ...and implementing global regulatory strategies. Establishes...Contract workLocal area- ...The role is for a CMC Regulatory Affairs Manager, responsible for day‑to‑day internal regulatory activities across development and marketed... ...the US. Assist and provide guidance to other departments and submission authors. Produce high‑quality regulatory submissions...Contract work
- ...Fate Therapeutics, Inc. is seeking a Director, Regulatory Affairs to manage global clinical regulatory activities in innovative biotechnology programs. This role includes overseeing IND submissions, ensuring FDA compliance, and collaborating with cross-functional teams...Full time
$228k - $245k
...A biotechnology firm is seeking a Director of Global Regulatory Affairs in San Diego. This role involves developing and executing regulatory strategies to support clinical programs and interaction with global regulatory agencies. Candidates should have a BS in life sciences...$187k - $233k
...rigorous innovation can lead to better lives. Our... ...related tumors. The Director, Global Product Leader is responsible for the strategic leadership of a... ...across development, regulatory, CMC, operations, and business... ...strategies and regulatory submissions.Drive the team to out...Work at officeLocal areaRemote work$90k - $105k
...Proven Recruiting seeks a Payroll Supervisor in San Diego to lead a payroll team within a mission-driven organization. The role involves overseeing payroll operations for 2,000 individuals, including foreign nationals, and ensuring compliance with taxation. The ideal...Remote work$252.5k - $344k
...Neurocrine Biosciences is a leading neuroscience-focused,... ...: The Executive Director, Regulatory Strategy -... ...for shaping and driving global regulatory strategy across... ...role requires a highly strategic, scientifically grounded... ..., Safety, Commercial, CMC, Quality, and Legal to...$189k - $246k
...Travere Therapeutics is seeking a Director, Global Compensation to develop and oversee national and international compensation programs. The ideal candidate has over 10 years of relevant experience, particularly in the Pharmaceutical or Biotech sectors. Responsibilities...- ...A leading systems integrator in San Diego is seeking an enthusiastic Program Manager to coordinate and manage programs for global accounts. You will lead operational activities, ensure high customer satisfaction, and support financial performance while being a key advocate...
$165k - $205k
...tandemdiabetes.comA DAY IN THE LIFE:The Director, Fulfillment & Inventory... ...for leadership of logistics, global inventory management,... ...F&IP is also responsible for:Leads monthly Sales & Operations Planning... .../HIPAA, and other legal and regulatory requirements.Maintains...Long term contractLocal areaRemote workWork visaFlexible hours1 day per week$180k - $210k
...and postdocs into leading edge scientists.... .... POSITION TITLE Director of Regulatory Affairs POSITION... ...experienced and strategic Director of Regulatory... ...and execute global regulatory strategy... ...responsible for regulatory submissions (including INDs),... ...development CMC/manufacturing...Flexible hours- 1 DexCom Inc is seeking a Lead Enterprise Communications Specialist, responsible for leading internal communication efforts across its global manufacturing network. This role ensures alignment in messaging across time zones and focuses on developing strategies that reach...Remote work
$105.8k - $176.3k
...Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring... .... Our future ambition is to become a leading consumer health technology company while... ...they are.This individual will serve as a strategic partner to leaders across Global Operations...Work at officeWorldwideHome officeShift work- ...Dickinson is seeking a highly experienced professional in San Diego to lead the development of category strategies and manage key supplier... .... The role requires 10+ years in primary packaging and global category management with a strong focus on quality improvement and...
- A leading travel technology firm is seeking a Manager/Senior Manager for Strategic Revenue & Growth Management. This role involves managing global marketing investments to optimize profitability using data-driven strategies. You'll lead cross-functional teams, influence...RelocationShift work
$130k - $250k
...Director, Regulatory Affairs FULLY REMOTE Assignment through... ...portfolio through CMC, Nonclinical, Regulatory... ...crafting regulatory submissions ~ Demonstrated... ...Direct experience in leading a monoclonal antibody... ...industry standards and global regulations, and are...Full timeTemporary workFor contractorsRemote work- ...Veeva Systems is seeking a Proposal Team Manager in San Diego, California. The successful candidate will lead a global team responsible for high-quality proposals in the R&D and Quality sectors. With over 7 years in proposal management and 2 years in people management,...
$181k - $226k
...Lead Global Product ManagerSkip to main contentThis website uses cookies to improve the... ...**Breathing Health is one of the most strategically important growth areas at Resmed spanning... ..., business development, finance, regulatory, and commercial teams globally to help...Temporary workWork experience placementFlexible hours- ...A global professional services firm is seeking a qualified Sales and Use Tax Manager to advise on compliance and optimization strategies... ...of experience in tax processes. The successful candidate will lead projects, engage with clients, and navigate complex tax systems,...Flexible hours
- ...Dexcom Inc. is looking for a Global Events Manager to lead and execute international and U.S.-based events. The role focuses on ensuring all events align with the marketing strategies and brand objectives. The ideal candidate should have significant experience in event...Remote workHome office
- ...Manager of Compensation Programs & Analytics. The role involves leading the execution of compensation and recognition programs while... ...compensation professionals. Key responsibilities include managing the global compensation planning cycle and ensuring pay structures align...
$204k
...A leading pharmaceutical company in San Diego seeks an Associate Director for Outsourcing & Vendor Governance. This role oversees strategic supplier management, ensuring compliance with regulatory standards and effective negotiations... ...of experience in CMC and external...
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