...The Position:
Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development... ...trials
Identify and assess regulatory risks associated with development programs and define strategies to mitigate...
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...small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
As the Director of Regulatory Affairs, Advertising and Promotion, you will report directly to the Executive Director, Regulatory Affairs. Your primary...
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...and development programs in oncology and muscular dystrophies.
Description
Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs - CMC will be responsible for leading, developing, and executing CMC regulatory strategies on programs...
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Full time
3 days per week
...our commitment to bettering the lives of patients and realizing a world where we make brain disorders history
The Associate Director, Regulatory Affairs is part of the Alector Regulatory Affairs team based in the San Francisco Bay Area. This individual will support...
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Flexible hours
2 days per week
...drug candidates specifically engineered to impact muscle function and contractility.
Reporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning...
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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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...JOB TITLE: Senior Director, Regulatory Affairs
DEPARTMENT: Regulatory Affairs
TYPE: Full-Time
HI-Bio, Inc. is a clinical-stage biotechnology... .../agency regulatory meetings, committees and trade associations
Champion our culture through living our values and mentoring...
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Full time
...please visit and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.
About the role:
The Senior Associate will support all aspects of regulatory affairs related to the development of novel CAR T therapies including quality, preclinical and clinical areas of...
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Full time
Internship
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...JOB TITLE: Director/Senior Director, Medical Affairs
DEPARTMENT: Clinical Development
LOCATION: South San Francisco, California
TYPE: Full... ...and clinical experts, publishers, medical and patient associations, and other relevant external and internal stakeholders...
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Full time
...Bayside Solutions is seeking a Director, Clinical Affairs IV to be part of our client' s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s Clinical, Clinic,...
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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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...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
...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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Full time
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...Vice President, Regulatory
About the Company
Reputable business in the science industry specializing in bio & machine learning... ...experience. A minimum of 10 years of experience in regulatory affairs within the biotechnology and/or pharmaceutical industries, with...
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...therapies.
Principal Responsibilities
Develop and implements regulatory strategies and contingencies for assigned programs, in order... ...Contribute to the development and maintenance of Regulatory Affairs working practices and procedures
Support in the preparation...
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...the Clinical Trial Quality Assurance Associate Director you will provide strategic leadership... ...quality excellence while aligning with regulatory requirements and industry best practices... ...development/operations, regulatory affairs, clinical supply management, data management...
Temporary work
Remote job
Flexible hours
...is seeking a highly motivated individual to join our team as Associate Director, Quality Systems. You will have the opportunity to create... ...compliance with company's procedures, company policies, and regulatory guidelines.
Responsibilities
Design, develop and deploy...
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...worldwide. Its time for a career you can be proud of.
Scientific Associate Director - Inflammation
**Live**
**What you will do**
Lets do... ...academic partners.
+ Ensure compliance with the ethical, regulatory, and quality standards and best practices.
**Win**
**What...
Remote job
Worldwide
Flexible hours
...support clinical development programs
* Contribute clinical pharmacology sections of clinical study protocols and reports and regulatory documents including Investigator Brochures, and NDA/IB/IMPDs
* Conduct hands-on non-clinical and clinical data analysis, including...
...innovative and highly motivated Principal Scientist, Scientific Affairs who will contribute significantly to the development and... ...product and project management, process and analytical development, regulatory and quality
~ Strong problem-solving skills and attention to...
Flexible hours
...data and contribute to the interpretation of results, drawing actionable insights to guide decision-making.
Prepare and review regulatory documents, including IND submissions, clinical study reports, and regulatory responses.
Serve as a key point of contact for...
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Flexible hours
Shift work
...developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
The Associate Director, Global Supply Planning plays a key role in the Cytokinetics Commercial Supply Chain. The role owns and optimizes the end-to-...
...Medicines on an exciting journey as our newest Principal Scientist/Associate Director, Process Chemistry - CMC, located at our South San Francisco... ...of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required
Ability to travel domestically...
Holiday work
Temporary work
...LinkedIn.
Job Description
Purpose
The Director, Statistics provides scientific and... ...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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...fundamentally change the outcomes for these patients.
The Associate Director, Data Management (AD, DM) will be responsible for ensuring... ...on time and in accordance with quality standards and regulatory requirements from study start-up through study closure/archival...
...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...
...* Structure Therapeutics is seeking a Director of Advocacy Engagement to connect the patient... ...to the Executive Director of Medical Affairs and Advocacy Engagement, this role will... ...Demonstrated understanding of the Legal, Regulatory, and Compliance environment, including a...
Full time
...Job Description
Job Description POSITION SUMMARY: Associate Director/Director Data Manager serves as an expert for clinical data management, whether directly or by way of managing or mentoring contractor data managers. They will lead cross-functional team members...
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Interim role
...our client, where they seek a dynamic Director/Associate Director driven by scientific creativity... ...and internal functions to facilitate regulatory submissions supporting CDx approvals.... ...Collaborate with clinical development, medical affairs, and commercial teams to strategize...
...POSITION SUMMARY:
The Associate Director, Clinical Study Management leads both indirect and direct reports, external partners, consultants... ...peers including Drug Safety, Clinical Quality Assurance, Regulatory Affairs, Clinical Development, Data Management and Statistics,...
Remote job
Hourly pay
Contract work