CMC Regulatory Strategy Executive Director
Allakos Inc
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
- ...Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings: 1 Allakos Inc. is a dynamic clinical-stage... ...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$265k - $331k
...are seeking a skilled and experienced Executive Director (ED) of Global Patient Safety (GPS) Quality... ...and Compliance is responsible for the strategy, development, oversight, and execution... ...Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical...RegulatoryFull timeContract workLocal area- ...Executive Director, Biostatistics Our client is an international biopharmaceutical company focused on improving patients' lives by identifying... ...statistical expertise and leadership in the development and regulatory approval process efforts for our clients Pharmaceuticals'...Regulatory
$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 programs... ...Practice (GCP), ICH guidelines, and regulatory requirements. Proven ability to...RegulatoryTemporary workFor contractorsLocal area$194k - $199k
...Princeton, NJ; Miami, FL Overview of Role The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating and preparing high‑quality... ...regulatory filings. This role will provide regulatory strategy input, and oversee preparation of regulatory submissions...RegulatoryWork at office$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- ...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
$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$158k - $198k
...and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will... ...position is responsible for developing and implementing global CMC regulatory strategies. The role involves coordinating CMC regulatory...RegulatoryFull timeLocal area$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...RegulatoryWork at officeLocal areaRemote workWorldwideFlexible hours$200k - $240k
...partner, and market-facing workflows. You will own product strategy and execution for a critical operational platform, working closely with the... ..., balancing customer needs, technical constraints, regulatory requirements, and business objectives. Partner closely with...RegulatoryFull timeWork at officeImmediate startFlexible hours3 days per week$215k - $222k
...is seeking a Principal Product Manager to help lead the strategy, roadmap, and execution of our emerging AI Agent platform, Agent Workbench. You'... ...systems, and govern their entire AI portfolio across complex regulatory environments, all on one unified platform. As the...RegulatoryRemote 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
- ...Executive Director or Vice President, Global Privacy About the Company Esteemed life science company developing innovative medical products... ...and implementation of a comprehensive global privacy strategy. The successful candidate will be a senior leader with a J.D...Worldwide
- ...approach Strictly adhere to all risk and control policies, regulatory guidelines and security measures Required Qualifications,... ...Management provides individuals, advisors and institutions with strategies and expertise that span the full spectrum of asset classes...RegulatoryTemporary workWork experience placementLocal area
- ...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
- ...on client experience and risk management Manage the area's revenue and profitability and monitor adherence to credit quality, regulatory requirements, and risk protocols; utilize reporting and metrics to monitor team performance, identify trends, and address or escalate...RegulatoryWork experience placementWork at officeLocal area
$291.72k - $343.2k
...Description As Vice President of Regulatory Affairs, you will oversee... ...to manage the regulatory strategy globally and be the key point... ...with the CEO, CTO, and the Executive Team to ensure that business... ...management and the Board of Directors. Other Qualifications Thorough...RegulatoryTemporary work$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- ...search of a Vice President, Global Privacy to lead the strategy, development, and execution of its Privacy Program. The successful candidate will be... ...Privacy will also be involved in risk management, regulatory engagement, and training to promote a culture of privacy...Regulatory
$300k - $375k
...of science, engineering, and regulatory experts to empower clients... ...global business development strategy and organization. Reporting... ...sound judgment, and a strong executive network with the ability to... ...Group Vice Presidents, Practice Directors, and Office Directors, the...RegulatoryWork at office- ...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
- ...will be accountable for the enterprise strategy, design, governance, and continuous optimization... ..., influence and drive decisions at an executive level, and lead the work presented to... ...in managing international scope and regulatory responsibilities. The role also demands...Regulatory
$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- ...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
$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$272k - $408k
...advancing a global public policy, regulatory, and geopolitical strategy that enables the Company's longterm... ...trusted advisor to the Board, CEO, Executive Team, and senior leadership, the PPGA... ...strategic advisor to the Board of Directors, Executive Chair, CEO, Executive Team...RegulatoryFull timeTemporary workWork at officeLocal areaWorldwideShift work- ..., robustness, reproducibility, and regulatory compliance. Lead and execute purification development, including... ...trends to PD and cross‑functional CMC teams. Support downstream material... ...filings, Process Monitoring and Control Strategies). Stay updated on industry trends...RegulatoryContract workWork at office
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