Senior Associate Director, Regulatory Operations
ACADIA Pharmaceuticals
Acadia Pharmaceuticals is seeking an Associate Director of Regulatory Operations to lead global submission planning, publishing, and information management. The role partners with Regulatory Affairs and cross-functional teams to ensure inspection-ready processes and systems. The position requires extensive experience with eCTD, EDMS, and regulatory publishing tools, along with strong leadership and strategic execution capabilities. #J-18808-Ljbffr
$146k - $182.5k
...Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The Associate Director, Regulatory Operations provides leadership for global regulatory submissions, regulatory information management, document management, and...SuggestedFor contractorsWork at officeLocal areaRemote workNight shift3 days per week- ...Moderna is seeking an Associate Director, PV Operations, PV Center of Excellence to oversee the Pharmacovigilance Quality Management System and ensure... ...role requires a strong background in pharmacovigilance, regulatory intelligence, and digital/AI‑enabled safety solutions,...Suggested
$142.5k - $256.5k
The Role:Moderna is seeking an Associate Director, PV Operations, PV Center of Excellence, responsible for... ...standards, business continuity, PV regulatory intelligence, digital and AI-enabled... ...Medical Affairs, Commercial, Digital, senior leadership, and regional teams to...SuggestedPermanent employmentFull timeWork at officeLocal areaWork from home$142.5k - $256.5k
...changing the biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management & Intelligence... ...closely with Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise Data, Digital...SuggestedPermanent employmentFull timeFor contractorsWork at officeWork from home$145.6k - $279.4k
...Job Description Summary The Associate Director, Regulatory Affairs – Biosimilars (US) leads U.S. regulatory strategy and execution for biosimilar... .... Partner with global development and technical operations teams to ensure high‑quality BLAs, amendments, and supplements...SuggestedWork at officeVisa sponsorshipWork visaRelocation package- ...Kardigan is seeking a Senior Director, CMC Regulatory to lead CMC regulatory strategies and drive global submissions for late-stage assets. The role reports to Head of CMC Regulatory and collaborates with cross-functional teams across development and manufacturing in Princeton...Senior
$166.7k - $215.7k
...greatest. Based in Japan with worldwide operations, we work across the continuum from... ...North America is actively seeking an Associate Director, Data Governance for our Enterprise Architecture... ...owners of each layer.Serve as a senior point of escalation for data...Summer workWork at officeLocal areaWorldwideFlexible hours- ...Senior Director, Global Regulatory Strategy, NeuroscienceWill be a key member of the GRSP Extended Leadership Team to ensure the development, implementation... ...:Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed...Senior
$145.6k - $279.4k
Associate Director, Regulatory Affairs - Biosimilars (US) Sandoz continues to go through an exciting and transformative period as a global leader... ...support. Partner with global development and technical operations teams to ensure high‑quality BLAs, amendments, and supplements...Work at officeRemote workRelocation packageFlexible hours- ...ANI Pharmaceuticals, Inc. seeks a Sr. Director of Clinical Development to provide strategic and operational leadership across all clinical functions, advancing the... ...oversees Clinical Development for scientific quality, regulatory compliance, and trial execution on a global...Senior
$169.22k - $253k
## Associate Director, IT Senior EngineerApplylocations: Princeton, NJtime type: Full timeposted on: Posted... .../AgentCore, Snowflake Cortex). Operating in a regulated pharmaceutical environment... ..., privacy‐by‐design, and pharma regulatory controls (GxP, 21 CFR Part 11);...SeniorTemporary workWork at officeLocal areaFlexible hours$222k - $303k
...science, we’re in. Are you?About the Role:We’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us expand what’s... ...partnership with the assigned Global Regulatory Lead, Regulatory Operations, and/or third-party service providers, ensure high-...SeniorFull timeLocal areaRemote workFlexible hours$196.7k - $353.4k
The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters... ...overall plans to Regulatory Affairs the Project Team and senior management, as relevant.May be responsible for line...SeniorPermanent employmentFull timeWork at officeWork from home$196.7k - $353.4k
The Role:Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address...SeniorPermanent employmentFull timeWork at officeWork from home$247k - $322k
...Senior Director, Clinical Operations Program Lead About Us Kardigan is a heart health company working... ...for leading all of the activities associated with the clinical studies for the asset... ...Leader, Clinical Development Lead, Regulatory Lead, and other relevant...SeniorFor contractorsLocal area$230.44k - $279.23k
...the careers of those who do it. The Senior Director, Compliance Policy & Education is a... ...establishes the strategy, governance, and operating model for these programs globally and... ...risks, business priorities, and regulatory expectations. Serve as the primary...SeniorHourly payFull timeSummer workLive inLocal areaRemote workWorldwideFlexible hours- Tris Pharma, Inc. in Monmouth Junction, NJ, invites applications for an Associate Director or Director, Advertising & Promotions to oversee regulatory review of promotional materials. The role reports to the Head of Regulatory Affairs Advertising and Promotion and supports...Senior
- ...Associate Director Of Commercial OperationsLocation: Pennington, NJ Work Arrangement: Hybrid Employment Type: Contract/Contract-to-Hire Travel... ...an execution-oriented Associate Director of Commercial Operations to help an emerging biopharmaceutical organization build the...Contract work
$200k - $300k
...significant contributions to the company's success. The Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy... ...Lead and drive the preparation for Agency meetings and associated briefing document preparation Lead and manage queries and...Senior$160k - $180k
...understand the criticality of operating a successful business and... ...NJ office for an experienced Associate Director or Director, Advertising & Promotions to join our Regulatory Affairs team. Title and salary... .... This position provides senior regulatory oversight for the...Full timeWork at office- ...Our client is seeking a strategic and hands-on Senior Manager, HR Operations to support their North America population. They are based in the Princeton, NJ area and offer a hybrid work schedule plus excellent benefit. This role is responsible for overseeing HR operations...SeniorFull timeLocal area
$120k - $222.5k
...PositionResponsible for managing day-to-day operations of pharmacy programs. This... ...has high exposure to senior management and requires a... ....RelationshipsReports to the Director, Alternative Models Operations... .../CMR, legal, compliance, and regulatory. Other internal relationships...SeniorTemporary workLocal areaFlexible hoursNight shift$120k - $222.5k
...potential?The PositionSupport the operations and execution of... ....RelationshipsReports to the Director, Patient Support Enablement.... ...Public Affairs, Public Policy, Regulatory, Legal, IT, Trade, Patient Safety... ...of pharmacy redemptions for Senior Management approvalOversees vendor...SeniorLocal areaFlexible hoursNight shift- ...clinical-and-commercial supply. Operating from two U.S.-based... ...Position Summary The Senior Manager, Quality Systems, will... ...Management System (QMS) and associated quality processes. This role... ...full compliance with GMP and regulatory requirements. The ideal candidate...SeniorContract work
- ...Novo Nordisk A/S in Plainsboro, New Jersey, is seeking an experienced Market Access Operations leader to manage day-to-day pharmacy program operations, drive new initiatives for patient support, and monitor budget efficiency across cross-functional teams. You will...Senior
- TechDigital Group is seeking a Data Center Services Technical Lead in New Jersey to manage 24/7 IT infrastructure, including Windows, VMware, Linux environments, and open systems. The role requires leading incident, problem, and change management while ensuring SLAs are...Senior
- ...Novo Nordisk is seeking an experienced Affordability Operations Manager to support the execution of affordability programs across Diabetes, Obesity and Rare Disease portfolios in the United States. You will collaborate with Enterprise Insights, Finance, Market Access...Senior
$265k - $285k
...The Sr. Director, Clinical Development, provides strategic and operational leadership across all clinical functions to advance... ...ensuring scientific excellence, regulatory compliance, and operational... ...business objectives. Serve as a senior leader on the Medical Affairs...SeniorFull timeContract workTemporary work- ...Entity: Clinical Care Associates (CCA) - Penn Primary Care (PPC) and... ...: Administration & Operations Location: North Central NJ Region... ...Operating Officer (ACOO), the Sr. Director of Regional Operations (DRO)... ..., Real Estate and Design, Regulatory and Compliance, Risk...SeniorFull timeImmediate startFlexible hours
$166.14k - $201.32k
...Associate Director role overseeing commercial ordering and operations technology solutions at RayzeBio, a Bristol Myers Squibb subsidiary... ...Track record partnering with senior stakeholders to build and... ...~ Strong understanding of regulatory compliance considerations including...
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