- 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 - $255,000 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.
-
Director, Regulatory Strategy
3 days ago
Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · 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 su ...
-
Director, Regulatory Strategy
1 week ago
Exelixis Alameda, United StatesSUMMARY/JOB PURPOSE: · Manages all regulatory activities for new development programs, pre-IND through BLA/NDA and post-approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Provides expertise ...
-
Director, Regulatory Strategy
16 hours ago
Exelixis Alameda, United StatesSUMMARY/JOB PURPOSE: · Manages all regulatory activities for new development programs, pre-IND through BLA/NDA and post-approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Provides expertise ...
-
Regulatory Strategy Consultant
6 days ago
Katalyst Healthcares and Life Sciences San Rafael, United StatesResponsibilities: Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate · In collaboration with regional regulatory representatives, ensu ...
-
Regulatory Strategy Consultant
12 hours ago
Katalyst Healthcares and Life Sciences San Rafael, United StatesResponsibilities: · Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate · In collaboration with regional regulatory representatives, en ...
-
Director, Regulatory Strategy
1 week ago
EXELIXIS Alameda, CA, United StatesSUMMARY/JOB PURPOSE:Manages all regulatory activities for new development programs, pre-IND through BLA/NDA and post-approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Provides expertise in t ...
-
Sr Director, Regulatory Strategy
2 days ago
Exelixis Alameda, United StatesSUMMARY/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 encompas ...
-
Associate Director, Regulatory Affairs
2 days ago
Cytokinetics South San Francisco, United StatesReporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. · **Responsibilities** ...
-
AbbVie South San Francisco, United States**Company Description** · The Precision Medicine Department at Abbvie is committed to advancing drug development and patient care through building a deeper understanding of disease biology and developing tools to optimize clinical decision making and customize treatment for indiv ...
-
Manufacturing Associate
6 days ago
Infobahn Softworld Inc South San Francisco, United States**What is a nice to have (but not required) skill,experience, education, or certification? **PhD 3 year+ is preferred · **Responsibilities include**: · - Innovate, develop, optimize, and scale-up purification processes · - Conceive and evaluate novel advanced separation technolog ...
-
Associate Director, Formulation Development
5 days ago
Pliant Therapeutics, Inc. South San Francisco, United StatesPliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology a ...
-
Branch Operations Manager
1 day ago
Liberty Bank, N.A. South San Francisco, United States**In a Nutshell**: · You will be responsible for the oversight and management of all functions and activities relating to the operations of our South San Francisco Branch. This includes the move of the branch to Millbrae in Spring 2024. · In addition, you will ensure that all ope ...
-
Manager, Quality Assurance
1 week ago
Cutera Brisbane, United States**Company Description** · We're Growing - With Growth Comes Opportunity · **Job Description** Position Summary**: · The individual is responsible for activities that lead to, and maintain compliance to/with Cutera's Quality Management System and maintains regulatory approval to m ...
-
Workday Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your · Internal Career Site · to apply for this job. · At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment ...
-
Director Facilities
21 hours ago
AHMC Healthcare Daly City, United StatesOverview: · The Director is responsible for the operation of the Facilities at Seton Medical Center and Seton Coastside including Engineering, Biomedical Engineering, Security, Telecommunications, and EVS. Responsible for guiding staff members in effective performance of their jo ...
-
Quality Assurance Manager
6 days ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality sub functions. · • Partners ...
-
Quality Assurance Manager
6 days ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality subfunctions. · • Partners ...
-
Wells Fargo San Francisco, United States**About this role**: · We are seeking a highly skilled and experienced treasury banking product expert to lead our Specialty Industry Vertical Product Management team, who will be responsible for developing and executing strategies to drive growth and profitability within our spe ...
-
Business Execution Consultant
1 week ago
Wells Fargo San Francisco, United States**About this role**: · Wells Fargo is seeking a Business Execution Consultant supporting Merchant Services. · **In this role, you will**: · - Participate in a variety of assigned and ongoing business operations to ensure success in meeting business goals and objectives · - Identi ...
-
Product Marketing Manager, Product Compliance
21 hours ago
Meta San Francisco, United StatesWe believe in the endless power of people when they come together. But we also believe strongly in our responsibility to minimize harm and keep people safe. In this role, you will be responsible for helping to shape roadmaps and develop and execute against launch plans for the in ...
Director, Regulatory Strategy - South San Francisco, United States - Alumis Inc.
Description
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
Director, Regulatory Strategy professionals in South San Francisco
-
Sanjay M. Satav
Sales & Business Development Manager