Senior Regulatory Strategy Lead, Biologics
Scholar-Rock
Scholar Rock is seeking an Associate Director, Regulatory Strategy in the greater Boston area to lead the development and execution of regulatory plans for clinical and pipeline programs. This role represents regulatory affairs on cross-functional teams and directs submissions and correspondence to agencies. The candidate will drive regulatory roadmaps, manage INDs/BLAs, and partner with stakeholders to identify risks and opportunities, ensuring timely and compliant program advancement. #J-18808-Ljbffr Scholar-Rock
$179k - $236k
...Chief Scientific Officer, this role leads DMPK and bioanalytical strategy across nonclinical and clinical... ...stakeholders Author nonclinical sections of regulatory filings (e.g., IND) and briefing... ...Familiarity with LNP platform biology and delivery landscape Familiarity...SeniorRegulatory- ...Integrated Bioanalysis (IBA) team seeks a senior bioanalytical leader to design and implement robust strategies across PK, PD, and immunogenicity,... ...assay development with CROs, and drive regulatory interactions globally. You will lead select programs, mentor scientists,...SeniorRegulatory
- Takeda seeks a leader to develop and advance Global Patient Access strategies across programs, ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycles. Based in Cambridge, MA, this hybrid role collaborates with global teams to deliver...SeniorRegulatory
- ...Description Job Description Scientist/Senior Scientist, Biology Lead – Kidney Experience About the... ...therapeutic hypotheses, delivery strategies, and biomarker plans · Contribute... ...chemistry, delivery, translational, regulatory, and external teams · Help...SeniorRegulatory
$212k - $333.19k
...antibody-drug conjugates (ADCs), complex biologics and small molecules. Our goal is... ...worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part... ...challenges and ideas into actionable strategies. You will set global regulatory...SeniorRegulatoryMinimum wageLocal areaRemote workWorldwide- ...Vertex Pharmaceuticals Inc. seeks a senior Business Engagement Lead to partner with Clinical Development and Early Development. You will translate... .... The role emphasizes stakeholder management, regulatory compliance, and collaboration with product, data, quality...SeniorRegulatory
$119.7k - $222.3k
...Sciences representative to lead the development and... ...(AI) enabled strategies to transform clinical... ...includes small molecules, biologics/therapeutic proteins,... ...and interactions with regulatory agencies, as appropriateProactively... ...to be considered for Senior Principal Scientist....SeniorRegulatoryFull time- Moderna Therapeutics in Cambridge, MA is seeking an Associate Director of Regulatory Data Management & Intelligence to define data strategy, governance, and the digital data ecosystem within Regulatory Information Management. You will own Veeva Vault RIM data capabilities...SeniorRegulatory
$145 - $170 per hour
...help you find your next opportunity. Senior Regulatory CMC Lead Compensation: $145.00 - $170.00... ...Regulatory CMC leadership for a global biologics program. This role will lead CMC activities... ...focus on Module 3, global regulatory strategy, and FDA/EMA interactions. Local...SeniorRegulatoryHourly payFull timeTemporary workLocal areaRemote workMonday to FridayShift work- Abacus Technology seeks an Acquisition Strategy and Documentation SME to support the C3I&N Directorate at Hanscom AFB. This full-time... ...MAJCOM stakeholders, prepare briefings and reports, and oversee regulatory documentation to meet cost, schedule, and performance...SeniorRegulatoryFull time
$105.8k - $175k
...good. Your impact We are seeking a Senior Environmental Permitting Lead to drive the successful planning,... ...for environmental permitting strategy, regulatory interface, and high-quality technical... ...environmental science, planning, biology, ecology, natural resources, or a...SeniorRegulatoryFull timeLocal areaRemote workShift work- ...Job Description Job Description Primary Responsibilities 1. Global Regulatory CMC Strategy Lead and drive the global Regulatory CMC strategy for biologic ADC programs. Provide strategic guidance for global MAA/BLA preparation and submission activities. Ensure...SeniorRegulatoryWork at officeRemote workFlexible hours
- ...Therapeutics is seeking a Senior Director, Brand Lead - US who will be responsible... ...executing the US brand strategy and commercial plan for ficerafusp... ...with Medical Affairs, Regulatory, Legal/Compliance, Market... ..., targeted therapies, biologics, or other complex specialty...SeniorRegulatoryFull timeTemporary workWork at officeLocal area3 days per week
$212k - $333.19k
...of my knowledge.Job DescriptionSenior Director, AIRx Discovery Biology Lead Takeda Research is constructing the Discovery Automation &... ...cycles, and connecting experimental biology to translational strategy and clinical outcomes. The AIRx Discovery Biology Lead combines...SeniorMinimum wageLocal areaRemote work$135.62k - $203.44k
...Gaithersburg, Maryland Reports to: Senior Director, Global Regulatory Strategy About Alexion For over 30... ...people living with rare diseases. We lead with breakthrough science, deep... ...across subject areas to turn complex biology into transformative medicines, learning...SeniorRegulatoryTemporary workWork at office$137k - $215.27k
About the role: Lead the development and advancement of Global Patient Access strategies across programs. Ensure strategies align with enterprise priorities, regulatory requirements, and product lifecycle needs, and support timely, compliant patient access globally. This...SeniorRegulatoryMinimum wageFull timeContract workLocal areaRemote workNight shift$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and... ...office.Key Duties & Responsibilities:Leads the development of regulatory strategy... ...Education & Experience:Bachelor's degree in Biology, Chemistry, or other related...SeniorRegulatoryFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$274k - $377k
About This Role:The Senior Director, Immunology Early Development Strategy & External Innovation, is... ...Clinical Pharmacology, Regulatory, Biostatistics, Clinical... ...Executive Director may lead selected programs or strategic... ...through proof of biology or proof of concept and...SeniorRegulatoryFull timeTemporary workLocal area- Precede Biosciences, Inc. in Cambridge, MA seeks an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs. This senior role owns submissions from strategy through approval and serves as the...SeniorRegulatory
$250k - $280k
...Senior Director, Biologics Drug Substance Development and Manufacturing About... ...shuttle technologies. Our lead program is KRSA-028, an investigational... ...and Module 3 Quality for regulatory submission and approval.... ...Establishes effective CMC strategies for biologics drug...SeniorRegulatoryContract workWork experience placement- Sanofi is seeking a Senior Manager of Regulatory Affairs Advertising and Promotion to independently review promotional materials and develop regulatory strategies for campaigns. The role includes serving as regulatory lead for product launches and providing input on labeling...SeniorRegulatory
$105k - $140k
About the RoleThe Senior/Lead Analyst, Private Credit Operations role will be responsible... ...teams who is motivated to learn about our strategies and opportunities within the private... ...trade execution processes.Stay abreast of regulatory requirements and understand investment...SeniorRegulatoryLocal areaRemote work$126k - $165k
...records and ensure compliance with institutional and regulatory guidelinesQualificationsPh.D. in Molecular Biology, Cell Biology, or a related field with 3-6+ years... ...activities that are part of their core business strategies and has been twice named to Fast Company’s annual...SeniorRegulatory$150.5k - $245.5k
...together:The successful candidate will lead the strategy and execution of complex early and... ...biomarkers.Lead the interaction with regulatory agencies and site ethic committees for... ...Preferred: Strong background in oncology, biology, molecular imaging and familiar with precision...SeniorRegulatoryFull time- Moderna seeks a Senior Manager, GRS Integration in Cambridge, MA to lead regulatory planning and execution for multiple programs. You will partner with GRLs, Country Regulatory Leads, and CMC teams to translate strategy into integrated plans, manage risks, and ensure timely...SeniorRegulatory
- ...of medical innovation? As the Senior Global Medical Affairs Leader... ...investment decisions, lead pre-launch scientific efforts... ...develops and leads bold medical strategies for MASH within the Weight Management... ...healthcare system pathways, regulatory landscapes, market access,...SeniorRegulatoryFull timeWorldwideRelocation package
- ...will be responsible for leading the design and... ...robust bioanalytical strategies, including, but not limited... ...addition to traditional biologics, and a background in immunology... ...will also work with regulatory agencies and health... ...manuscripts. As a senior member of the IBA Global...RegulatoryHourly payTemporary workImmediate start
$110k - $160.91k
...essential. This role is focused on leading and overseeing routing and... ...stakeholder engagement, and regulatory documentation and state... ...Electric Transmission Line Siting Senior Lead, you will serve as a... ...overseeing routing and siting strategies, managing project execution,...SeniorRegulatoryFull timeFixed term contractCasual workWork at officeRemote workFlexible hoursShift work- ...Supply Chain in the Cambridge, MA area. This senior leadership role drives planning, readiness,... ..., supply chain, manufacturing, quality, and regulatory teams. You will develop launch strategies, identify risks early, and lead cross-functional decision-making to accelerate...SeniorRegulatory
- ...analytical and scientifically curious Senior Analyst to support strategic... ...intelligence, commercial strategy and early drug development in... ...development strategy and regulatory pathwaysExperience with a range... ...novel and proprietary biological, industrial, and engineering...SeniorRegulatoryWork at office
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