Associate Director, Global Nonclinical Safety & Regulatory
Novartis Group Companies
Novartis Group of Companies in Cambridge, MA seeks an Associate Director to provide global, end-to-end nonclinical safety leadership across multiple therapeutic areas and modalities. You will serve as the PCS authority on cross-functional R&D teams and interactions with global Health Authorities to ensure robust, regulatory-compliant safety strategies that enable clinical trial initiation and registration. You will guide safety programs, lead Health Authority negotiations, author nonclinical #J-18808-Ljbffr Novartis Group Companies
$152.6k - $283.4k
...Description Summary Internal Title: Associate Director #LI-Hybrid Location: Cambridge,... ...this key role you will provide global, end to end nonclinical safety leadership across multiple... ...scientifically robust, fit for purpose, and regulatory compliant safety strategies that...Regulatory- Job DescriptionThe Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products... ...external stakeholders in the medical community as well with global regulatory authorities.1. Manage safety surveillance for assigned...RegulatoryWorldwide
- ...seeking a highly motivated Associate Director or Director of Toxicology... ...the design and execution of nonclinical safety studies across our RNA... ...development candidate selection and regulatory submissions. Serve as the... .... Deep knowledge of global regulatory expectations,...RegulatoryFlexible hours
- ...seeking a highly motivated Associate Director or Director of Toxicology... ...the design and execution of nonclinical safety studies across our RNA... ...development candidate selection and regulatory submissions. Serve as the... .... Deep knowledge of global regulatory expectations,...RegulatoryFlexible hours
$90k - $115k
Associate Director, Global Quality (R&D) Pay Range: $90,000.00 - $115,000.00 per year Travel may be... ...alignment with international regulatory standards while driving inspection readiness... ...(IR) function , ensuring both nonclinical and clinical teams are consistently...RegulatoryWork experience placementRemote workWorldwideShift work$163.2k - $244.8k
Job DescriptionGeneral Summary:The Associate Director, Global Submission Management (GSM) is responsible for the strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs. This role will manage submissions...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$154.4k - $242.55k
...Associate Director, Statistics Are you looking for a patient-focused, innovation... ...work. Certified as a Global Top Employer, we offer... ...Sciences, Programming, Patient Safety & Pharmacovigilance, and Strategic... ...rigor and compliance with regulatory standards in all decision-...RegulatoryMinimum wageFull timeTemporary workWork at officeLocal areaRemote work$200k - $300k
...DescriptionGeneral Summary:The Patient Safety Associate Medical Director will provide medical safety... ...the Pharmacovigilance regulations of Regulatory Agencies around the globe, through the... ...HybridCompany InformationVertex is a global biotechnology company that invests in...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week- Job DescriptionGeneral Summary:The Patient Safety Epidemiology Associate Director leads safety and regulatory epidemiology activities for Vertex products across multiple... ...meetings including Disease Area Safety Teams and Global Patient Safety staff meetingsCollaborates cross-...RegulatoryFull timeSummer workWork at officeRemote workFlexible hours2 days per week
$172k - $237k
About This Role As the Associate Director for the Safety Surveillance and Aggregate Reports group, you will... ...Affairs, Clinical Operations, and Regulatory colleagues.Respond to regulatory requests... ..., ensuring strict compliance with global PV regulations as well as process...RegulatoryFull timeTemporary workWork at officeLocal area$154.4k - $242.55k
...Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU)... ...experience in the biopharmaceutical industry (e.g., safety, ad promo, regulatory strategy, medical affairs,...RegulatoryMinimum wageTemporary workLocal area$183k - $252k
About the RoleThe Global Associate Medical Director, Evidence Generation and Education is a key member of the Global Medical Rare Disease team, reporting... ...Economics and Outcomes Research, Value and Access, Regulatory, Patient Advocacy, Regional Medical, Commercial,...RegulatoryFull timeTemporary workLocal areaWorldwide$154.4k - $242.55k
...DescriptionObjective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives... ...their regional counterparts.Accountabilities:The Associate Director will be responsible for complex or highly complex...RegulatoryMinimum wageTemporary workLocal areaRemote work$170k - $210k
...Associate Director, Toxicology Cambridge Parabilis Medicines is a clinical-stage biopharmaceutical... ...Director, Toxicology to lead nonclinical safety programs across a diverse pipeline... ...based on scientific rationale and regulatory expectations Author and own...RegulatoryContract workInterim roleLocal areaShift work$119.7k - $222.3k
...member of myGwork – the largest global platform for the LGBTQ+... ...line function of Preclinical Safety (PCS). Key areas of responsibility... ...(Standard for Exchange of Nonclinical Data) packages to provide support... ...in GLP setting, and general regulatory compliance and animal welfare...RegulatoryPermanent employment$154.4k - $242.55k
...push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$126k - $190k
The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS... ...cross-functional team members within the global regulatory framework.You will be responsible for:Managing...RegulatoryFull timeTemporary work$194k - $267k
About This Role As the Associate Medical Director, Global Drug Safety, you will play a pivotal role in safeguarding patient well-being and shaping the safety strategy for both investigational and marketed products across our portfolio. In this highly visible position,...Full timeTemporary workLocal area$135k - $225k
...reimbursement, product commercialization, and regulatory and compliance solutions. Do you think... ...our communities.What You Will Do:The Global Market Access team provides... ...across major and emerging global markets.Associate Directors are key members of the Global Market Access...RegulatoryFull timeWork experience placementImmediate startRemote workFlexible hours$169.4k - $266.2k
...empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Director, Global Scientific Communications Group Lead. This... ...including ideas for sub-analysesCompliance and Regulatory: Excellent understanding of regulatory,...RegulatoryMinimum wageTemporary workFor contractorsFreelanceLocal areaRemote work- ...Therapeutics in the United States is seeking an Associate Director, Labeling and Disclosures to lead global labeling for development and marketed products and... ...will partner with cross-functional teams, ensure regulatory integrity, and drive compliant labeling strategies...RegulatoryWorldwide
$238k - $374k
...my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you... ...while ensuring product quality, patient safety, and inspection readiness.A key... ..., Regulatory, Development, Clinical, Nonclinical, Quality, Safety, Manufacturing, Supply...RegulatoryMinimum wageTemporary workLocal areaRemote work$152k - $209k
...in neuroscience. The role of the Associate Director requires the ability to provide regulatory strategic advice primarily for U... ...role may also require review of global, corporate, clinical trial, and... ...information and product efficacy/safety data Demonstrates strong...RegulatoryTemporary workWork at officeLocal area$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across various communication channels. This role will serve as a key liaison...RegulatoryWork at officeWork from home- ...being evaluated in MIST, a global Phase 2b clinical trial... ...demonstrated encouraging safety and clinical activity across... ...: Reporting to the Director, Product Development, the Associate Director, Analytical Development... ...(PPQ) batches, regulatory submissions, and future commercial...RegulatoryContract workLocal area
$185.37k - $308.95k
Associate Director, Medical Review Lead, MSRM Who we are At Agios, we are fueled... ...organization within Medical Safety & Risk Management (MSRM).... ...ensuring medical accuracy, regulatory compliance, and high-quality... ...and partners closely with Global Safety Leads, Pharmacovigilance...RegulatoryTemporary workRemote workWork from homeFlexible hours3 days per week- ...leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role... ...in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and leadership...Regulatory
- Takeda's Plasma-Derived Therapies (PDT) R&D Organization in Cambridge, MA is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to steer labeling strategy across US and EU. You will work with Clinical, Pharmacovigilance, Legal, and Commercial teams...Regulatory
$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across various communication channels. This role will serve as a key liaison...RegulatoryPermanent employmentWork at officeWork from home$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence... ..., your role is pivotal in aligning with ICH Q9 and global regulatory expectations. Reporting to the Director of Quality Risk...RegulatoryFull timeTemporary workLocal area
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