Average salary: $287,500 /yearly
More stats ...science and healthcare enable the entire healthcare ecosystem to drive better health outcomes.
Description
As a Senior Regulatory Affairs Specialist at Verily, you will work directly with other Regulatory Affairs team members, partners, and a team of experts from...
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...global pharmaceutical company specialized in autoimmune, oncology and ophthalmic diseases.
POSITION SUMMARY
The Director of Global Regulatory Affairs will serve as a pivotal member of the organization, overseeing regulatory strategies and operations, particularly...
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...in both the US and China and capitalizing on the strengths of each geographic location.
Position Summary
The Senior Director of Regulatory Operations will be responsible for carrying out the planning, scheduling, and coordination of submission obligations, in collaboration...
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...Description
Key Responsibilities
Responsible for providing regulatory strategy & support for global development.
Responsible for... ...communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial....
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...visit and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.
About the role:
Allogene is seeking a Senior Director, CMC Regulatory Affairs to provide support for products under development and lead CMC product strategy and provide regulatory direction to...
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...provide leadership and support to global regulatory activities to achieve Alumis’ strategic... ...The individual will represent Regulatory Affairs and work closely with cross-functional... ...This role will report to the Executive Director and Head of Regulatory Strategy.
Essential...
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Worldwide
Don't see what you're looking for but are interested in positions related to Clinical Development? Apply here to submit your resume for general consideration! Although this is not an active job posting, we will keep your resume on file and may reach out if your skills ...
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...LinkedIn.
About the role:
Allogene is seeking a Medical Director/Senior Medical Director for our allogeneic CAR T cell... ...to expedite execution of clinical trials
Support regulatory activities, medical affairs, and payer engagements; represent Allogene in external...
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...Clinical Trial Quality Assurance Associate Director you will provide strategic leadership... ...quality excellence while aligning with regulatory requirements and industry best practices... ...clinical development/operations, regulatory affairs, clinical supply management, data...
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...impact myocardial muscle function and contractility.
As the Director, External Supply Operations, you are responsible for... ...collaborating with other members of Supply Chain, Quality Assurance, Regulatory Affairs, and Finance to execute and deliver endorsed global supply...
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..., California. For more information, visit
We are seeking a Director, Facilities Operations to join our dynamic team. This critical... ...of those years from within San Mateo County to navigate local regulatory landscapes efficiently. This hands-on role will involve management...
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...Job Description
The Senior Medical Director leads the direction, planning, execution... ...principles, knowledge of compliance and regulatory requirements, AbbVies customers, markets... ...disease area(s); partners with Medical Affairs, Commercial and other functions in these...
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...Corporate Headquarters (South San Francisco, CA) - Hybrid
Position Summary
The Director/Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented...
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...individual will also be responsible for tracking PharmDev reports and documentation, timelines, budgets, invoices, and assisting with regulatory filings.
Essential Functions
Support the PharmDev teams to ensure uninterrupted clinical supply.
Collaborate closely...
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...seeking a highly motivated individual to join our team as Associate Director, Quality Systems. You will have the opportunity to create and... ...compliance with company's procedures, company policies, and regulatory guidelines.
Responsibilities
Design, develop and deploy...
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...Job Description
Purpose
The Director, Statistics provides scientific and statitical... ...works in partnership with clinical and regulatory experts to advance medicines to our... ...Data science experts
Global Medical Affairs experts
Regulatory experts
Additional...
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In House Counsel Jobs California | JDHuntr 35086 Executive Director, Government Affairs & Policy (re
In House Counsel Jobs California | JDHuntr 35086 Executive Director, Government Affairs & Policy (remote), South San Francisco, CA\
To apply go to JDHuntr.com \
Develop proactive strategic and tactical plans to engage with key decision makers to shape CMS regulations...
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...reports into the Vice President of Global Clinical Operations. The Director/Sr. Director will contribute to the development and... ...(SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements. Establish and lead meetings with CROs and other...
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...muscular dystrophies.
Description
The Director of Clinical Quality Assurance (CQA) is a... ...GCP QA in compliance with applicable regulatory requirements (US and OUS), and company... ...functional areas, including regulatory affairs, and development operations, as appropriate...
Full time
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...myocardial muscle function and contractility.
As the Associate Director, Clinical Quality Assurance (CQA), you are a key member of the... ...regulations to drive and maintain quality standards and regulatory compliance culture at Cytokinetics. The ideal candidate has a...
Local area
...patients.
Alumis is hiring a Clinical Quality Assurance Director, reporting to the Sr. Director GCPQA. The role works closely... ..., Clinical Development, Clinical Supply Chain, Medical Affairs, Regulatory, Legal, and other teams across Alumis.
The Clinical QA...
...The Position:
Are you ready to take the helm of discovery efforts in our DMPK group at Maze? As an Associate Director, you'll be at the forefront of driving our mission forward, supporting discovery projects from hit-to-lead (H2L) through investigational new drug (...
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...commitment to bettering the lives of patients and realizing a world where we make brain disorders history
Reporting to the Sr. Director, People & Business Partnering, the Director, People Operations will be the main strategist for the People Team's platforms, processes...
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2 days per week
3 days per week
...saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join our... ...cross-functional colleagues all clinical-regulatory documents, including IND/CTAs, clinical... ...DMPK, nonclinical development, regulatory affairs and other stakeholders
As a Senior...
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...Position Description:
For the Biologics Drug Product R&D Director position, we are seeking a highly motivated, experienced leader... ...functional deliverables including reports and applicable quality and regulatory documents.
+ Implement and manage functional processes and...
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...medicines. We're looking for an Associate Director, Clinical Science to join our Clinical... ...assets at Maze
Author and review clinical-regulatory documents, including protocols and... ...CMC, nonclinical development, regulatory affairs, and other stakeholders.
Skills and Qualifications...
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...what is and will be outsourced.
This role is located in Cytokinetics' South San Francisco headquarters reporting to the Executive Director, IT
Responsibilities:
Oversee the enterprise IT implementation and operation of foundational technologies, processes, and...
...empowerment, exemplary professional practice, new knowledge, and empirical outcome.
Coordinates activities with Nursing Leadership (CNE, Directors and Nurse Managers). Facilitates and supports the design and execution of nursing research projects and practice and ensures...
Full time
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...Title: Director, GMP QA
Company Overview: our client is a dynamic and innovative small molecule biotech company committed... ...functional teams, including manufacturing, quality control, regulatory affairs, and supply chain, to ensure alignment and consistency in quality...
Worldwide
...strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports.
+ Apply current regulatory guidance as appropriate for safety surveillance and authorship...
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