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BioSpace, Inc.
South San Francisco, CA, United States
Job Details Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an except
Job Source: BioSpace, Inc.Alumis Inc
South San Francisco, CA, United States
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motiv
Job Source: Alumis IncExelixis
Alameda, CA, United States
SUMMARY/JOB PURPOSE: Manages all regulatory activities for new development programs, pre-IND through BLA/NDA and post approval, with a particular focus on biologics (ADCs, bispecifics, and etc.). Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines, as well as companion di
Job Source: ExelixisAstranis
San Francisco, CA, United States
[Full Time] Manager, Regulatory Strategy at Astranis (United States) | BEAMSTART Jobs Manager, Regulatory Strategy Astranis United States Date Posted 31 Oct, 2022 Work Location San Francisco, United States Salary Offered Not Specified Job Type Full Time Experience Required 3+ years Remote Work No Stock Options No Vacancies 1 available Astrani
Job Source: AstranisDompé farmaceutici S.p.A.
Oakland, CA, United States
Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: We seek enthusiastic, resilient professionals to join Dompé’s US regulatory affairs department.The candidate reports to the Global Regulatory Affairs Senior Director and will play an important role within the Reg
Job Source: Dompé farmaceutici S.p.A.EMC Research
Oakland, CA, United States
National Polling and Market Research firm seeks Director, Strategy . EMC Research, Inc. is a majority women-owned national full-service opinion research firm specializing in polling, focus groups, analytics and public opinion research consulting. Our mission is: to partner with our clients to solve problems through well-executed research conducte
Job Source: EMC ResearchAbdera Therapeutics
South San Francisco, CA, United States
Salary Range : US$ 200K - $270K Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to s
Job Source: Abdera TherapeuticsAbdera Therapeutics
South San Francisco, CA, United States
Salary Range : US$ 200K - $270K Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes
Job Source: Abdera TherapeuticsSouth San Francisco, CA, United States
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
We are seeking an exceptionally motivated individual to provide leadership and support to global regulatory activities to achieve Alumis’ strategic vision of obtaining worldwide approvals to market our products. The individual will represent Regulatory Affairs and work closely with cross-functional teams and development partners while managing relationships and interactions with external strategic and technical regulatory service providers in accordance with health authority and ICH requirements. In addition to being a key member of our project teams, she/he will provide organizational support as the company and its product development pipeline grow. This role will report to the Executive Director and Head of Regulatory Strategy.
Essential Duties & Responsibilities
Develop and implement regulatory strategies to facilitate the progress of assigned programs in all phases of development.
Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions, and feedback to the teams in support of regulatory approvals.
Lead interactions with regulatory agencies for assigned programs
Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for global NDAs / MAAs.
Interact with Regulatory Affairs personnel within external service providers
Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.
Education | Experience | Skills
Bachelors or advanced degree in a scientific discipline, with a minimum of 10 years of experience working in drug development in the biopharmaceutical industry and at least 8 years of experience in Regulatory Affairs; immunology or rare disease/ orphan drug development experience desirable.
Knowledge | Skills | Abilities
Direct experience with pharmaceutical regulatory submissions and product approvals, contributing to major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA.
Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
Experience leading regulatory agency interactions.
Demonstrated leadership and success in management of regulatory activities and previous experience in successfully leading assigned activities within cross-functional teams.
Experience in providing strategic advice on integrated regulatory development plans and life cycle management.
Excellent verbal and written communication skills.
Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others; prior management experience a plus.
Previous experience in successfully leading assigned activities within cross-functional teams.
Some travel required. Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
Alumis Values
Elevate
Challenge
Nurture
This position is located in South San Francisco, CA. At this time we are not considering remote applicants.
The salary range for this position is $225,000 - $250,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company’s compensation practices.
Alumis Inc. is an equal opportunity employer.
Email Alert for Director, Regulatory Strategy jobs in South San Francisco, CA, United States
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