CMC Regulatory Strategy Executive Director
Allakos
A biopharmaceutical company in Redwood City is seeking an Executive Director of Regulatory Affairs CMC to lead the regulatory strategy for drug products. The ideal candidate will have 15 years of regulatory CMC experience and a successful track record in preparing BLAs. This role involves close collaboration with internal teams and regulatory authorities to ensure compliance and optimize submission processes. Competitive salary based on experience. #J-18808-Ljbffr Allakos
- Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings: 1 Allakos Inc. is a dynamic clinical... ...for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and...Regulatory
$290k - $320k
...committed to advancing novel therapeutic strategies that address this rare and complex... ...Familiarity with current legal and regulatory landscape pertinent to the pharmaceutical... ...currently anticipates the base salary for the Executive Director, Payer Strategy and Engagement role...RegulatoryContract workWork at officeLocal areaHome office3 days per week- ...for patients with cancer. Overview The Director, Regulatory CMC, is responsible for leading one or... ...specific emphasis on global regulatory strategy, regulatory submissions, and interaction... ...teams and with health authorities, 3) execute clinical-regulatory development plans...RegulatoryWork at officeRemote work
$180k - $210.5k
...and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation... ...Canada and ICH) guidelines Reports to: Executive Director, CMC Regulatory Location: San Carlos, CA / US...RegulatoryRemote work$25 per hour
...residents and for our team members. We’re looking for an Executive Director (ED) to lead The Terraces at Los Altos (TLA), a vibrant Life... ...regulations that may impact Community operations and ensures regulatory compliance; directs all records/reports required by...RegulatoryLocal area- ...Dialysis Services team. Position Overview : As the Executive Director of Dialysis Services , you will oversee the administration... ...efficiency of our dialysis services, ensuring compliance with regulatory standards and best practices in patient care. Key Responsibilities...RegulatoryRelocation package
- ...Chief Executive Officer (CEO) About the Company Mission-driven healthcare organization... ..., including reimbursement models and regulatory landscape, to navigate and advocate for... ..., and developing long-term strategies for expansion beyond California. Operationally...Regulatory
- ...Chief Executive Officer (CEO) About the Company Mission-driven healthcare organization... ...a focus on geographic expansion, payer strategy, and strategic partnerships. This role requires... ...Care Plans, reimbursement models, and regulatory landscape. The CEO will be tasked with...Regulatory
$194k - $199k
...therapy not presently approved by any regulatory authority other than China's... ...Overview of Role: The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating and... .... This role will provide regulatory strategy input, and oversee preparation of regulatory...RegulatoryWork at office$302.01k - $390.83k
...Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Medical Affairs... ...according to priorities and business strategies. Negotiates project timelines across... ...Practice (GCP), ICH guidelines, and regulatory requirements. Proven ability to supervise...RegulatoryTemporary workFor contractorsLocal areaWorldwide$186k - $233k
...RAS signaling pathway. Opportunity The COST – Vendor Associate Director leads the end-to-end outsourcing of one or more indications... ...s) clinical trial operations. Working knowledge of applicable regulatory, ICH and GCP. Grant Plan or Grant Manager experience. Global Project...RegulatoryContract work$285k - $345k
Overview Piper Companies is currently seeking an Executive Director of Medical Writing in Palo Alto, California. The Executive Director will... ...writing activities across clinical development programs, regulatory submissions, public disclosure deliverables, and cross-functional...Regulatory- ...energy. Role As Chief of Staff, you'll work directly with the executive team across strategy, operations, and customer pipeline. You'll drive analyses... ..., coordinate execution across engineering, finance, and regulatory, and help build out the team as we scale....RegulatoryWork experience placementVisa sponsorshipWork visaWeekend work
- ...between vendor oversight and health plan strategy and you’re passionate about equitable... ...ensure the team has clear answers. Support Executive Bandwidth – shield the CEO’s time from... ...relations. Experience navigating multi-state regulatory or licensing environments in healthcare....RegulatoryContract workRemote workHome office
$300k - $400k
...and dispute resolution, world-class regulatory compliance and advisory services,... ...forward-thinking peers. The Managing Director, Technology is a senior technology... ...Chief Digital & Technology Officer to execute the firm’s technology strategy, modernize foundational platforms,...RegulatoryContract work$216k - $298k
...Director, External & Executive Communications Menlo Park, California, United States; New York, New... ...external and executive communications strategy. As Moloco continues to rapidly grow... ...dynamics. Navigate cultural and regulatory differences in communications...RegulatoryTemporary workWork at officeLocal areaFlexible hours$208k - $260k
...platforms. You will lead the "upstream" strategy—identifying unmet clinical needs and translating... ...of hardware, software, AI, and strict regulatory environments to deliver transformative... ...business plans, revenue models and executive facing presentations based on procedure...RegulatoryFull timeWork at officeLocal areaRemote workWorldwideFlexible hours- ...facilitate cross-functional execution, and support the successful... ...meetings, Board of Directors meetings, and key business... ...research, business operations, strategy, or a related field, with direct... ..., program management, regulatory/or CMC a plus. Demonstrated ability...RegulatoryFull timeLocal areaImmediate startRemote workShift work
- ...experienced new member of our Regulatory team who will own the strategy and operations for our... ..., and Controls (CMC) regulatory work. As one... ...roll up your sleeves to execute them at speed. You are energized... ...this role is approximate to Director level. Total...Regulatory
$291.72k - $343.2k
Description As Vice President of Regulatory Affairs, you will oversee... ...to manage the regulatory strategy globally and be the key... ...with the CEO, CTO, and the Executive Team to ensure that business... ...management and the Board of Directors. Other Qualifications Thorough...RegulatoryFull timeTemporary work- ...the short, medium and long term through a holistic goal‑based planning approach Strictly adhere to all risk and control policies, regulatory guidelines and security measures Required Qualifications, Capabilities, And Skills Six plus years of work experience in Private...RegulatoryTemporary workWork experience placementLocal area
- ...excellence. Program Manager Role Required Credentials: Program Managers must hold active state licensure in accordance with local regulatory requirements and/or maintain certification as a Board Certified Assistant Behavior Analyst (BCaBA) or higher. Additional state...RegulatoryFull timePart timeLocal areaFlexible hours
$300k - $375k
...global business development strategy and organization. Reporting... ...Responsibilities Developing and executing a firm‑wide business... ...senior corporate, legal, and regulatory buyers Monitoring market, industry... ...Vice Presidents, Practice Directors, Office Directors, and consultants...RegulatoryWork at office$211.39k - $359.93k
...provide vision for its global privacy strategy. The CPO oversees the company’s global... ...range of stakeholders, including senior executives, product teams, engineers, and business... ...effective compliance with a rapidly evolving regulatory environment. The CPO is expected to...RegulatoryWork at officeLocal area$272k - $408k
...advancing a global public policy, regulatory, and geopolitical strategy that enables the Company's long-term... ...trusted advisor to the Board, CEO, Executive Team, and senior leadership, the PPGA... ...strategic advisor to the Board of Directors, Executive Chair, CEO, Executive...RegulatoryFull timeTemporary workWork at officeLocal areaWorldwideShift work$70k - $78k
...services. Case Management & Compliance: Oversee person-centered planning, documentation, case management, and ensure compliance with regulatory requirements. Participant & Family Support: Build meaningful family relationships, guide intake activities, and support...RegulatoryFull timeMonday to Friday$310k - $360k
...Responsibilities Provide scientific strategy and operational leadership across the... ...nonclinical‑to‑clinical biomarker strategy and execution. Drive clinical biomarker... ...closely with Clinical Development, Global Regulatory Affairs, CMC, and Research to deliver integrated...RegulatoryFull timeFlexible hours- ...across research, development, regulatory, and operational functions.... ...thoughtful design and agile execution, Fortvita is working to translate... ...the Clinical Operations strategy aligned with a lean, in‑house... ...Development, Regulatory, Biometrics, CMC, and other functions to...RegulatoryContract workLocal areaWorldwide
$164k - $205k
...diagnostic partners to enable successful clinical development, regulatory execution, and commercialization readiness. The successful candidate... ...supporting clinical-stage oncology assets from assay strategy through clinical and regulatory execution. Work closely with...RegulatoryFull timeLocal area$207.5k - $281k
...over the world! We are seeking a Principal Regulatory Compliance Manager to serve as a senior... ...contribute to the design and execution of compliance monitoring, testing, and control... ...regulatory examinations, including exam strategy, document production, regulator-facing interactions...Regulatory3 days per week
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