- As a member of the CMC project teams, provide strategic CMC regulatory leadership support for multiple innovative Allogeneic CAR T programs.
- Provide CMC expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs).
- Primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for CMC related issues.
- Lead negotiations with regulatory agencies to resolve CMC issues and oversee proactive interactions with regulators globally (US, EU and Japan) for initial INDs/CTAs, marketing registration applications, supplements and variations.
- Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Responsible for compilation, review, approval and submission of high quality CMC related sections of INDs/CTAs, including responses to questions from various regulatory authorities, working in collaboration with SME's in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners. Maintain responsibility for all CMC Regulatory timelines.
- Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
- Support interactions with regulatory agencies during inspections.
- Manage contract staff and vendors as needed to support regulatory activities.
- Other duties as assigned.
- Advanced scientific degree preferred in the sciences, or health related field or equivalent experience
- CMC regulatory experience in the pharmaceutical/biotech industry
- Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of Cell Therapy
- Established working knowledge of regulatory guidelines and regulations including Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines (e.g., ICH, FDA and EMA guideline)Regulatory experience supporting both development projects and marketed products including support of post-approval dossier life cycle management
- Experience with Orphan Drug Designation, BTD, RMAT, direct interactions supporting health authority GMP inspections desirable is preferred
- Prior supervisory experience preferred
- Strong knowledge of eCTD elements and structure including CMC-regulatory writing skills
- Ability to work in a fast-paced, start-up environment
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Ability to work independently and as part of a team and drive results
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Candidates must be authorized to work in the U.S.
-
Associate Director, Regulatory Affairs
4 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** ...
-
Regulatory Affairs Specialist
1 week ago
Synergy Solutions Hercules, United StatesEssential Onsite · - no hybrid. M-F 8:00 to 4:30 however we are flexible. · *Less than 1 year experience in IVD medical device industry is acceptable* · - Provide regulatory support for IVD products with multiple product groups within clinical diagnostics. · - Work with regulator ...
-
Director, Regulatory Affairs
1 week ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expe ...
-
Director, Regulatory Affairs
1 day ago
Maze Therapeutics South San Francisco, United StatesJob Description · Job DescriptionThe Position: · Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a stra ...
-
Regulatory Affairs Manager
2 weeks ago
Allergan South San Francisco, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
-
Regulatory Affairs Manager
2 weeks ago
AbbVie South San Francisco, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
-
Regulatory Affairs Manager
1 day ago
AbbVie South San Francisco, United StatesJob Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...
-
Director, Regulatory Affairs
2 days ago
Mazetx South San Francisco, United StatesBecome a genetic navigator. · Our mission is to discover new genetic insights and translate them into new precision medicines. With an unparalleled commitment to changing the way people with severe diseases are treated, our team is at the forefront of accelerating our understand ...
-
Regulatory Affairs Specialist-4694
1 day ago
Infosoft Palo Alto, United StatesOne of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position. · Here are the job position details for ...
-
Head of Regulatory Affairs, Oncology
1 week ago
Ascendis Pharma Palo Alto, United StatesHybridPalo Alto, California, United StatesOncology, Regulatory, OncologyFull time1404 · Description · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncol ...
-
Sr. Director Regulatory Affairs
1 week ago
Life Science People South San Francisco, United StatesSenior Director of Regulatory Affairs · Menlo Park, CA · Life Science People are currently working with an exciting client, looking for a Sr. Director Regulatory Affairs professional with a strong background in oncology submissions. · My client is looking for someone to come in ...
-
Senior Regulatory Affairs Specialist
2 days ago
Verily South San Francisco, United StatesWho We Are · Verily is a subsidiary of Alphabet · that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every da ...
-
Senior Regulatory Affairs Specialist
1 week ago
Verily South San Francisco, United StatesWho We Are · Verily is a subsidiary of Alphabet that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day. W ...
-
Senior Director, Regulatory Affairs
4 days ago
ALX Oncology Inc. South San Francisco, United StatesALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 bind ...
-
Global Director of Regulatory Affairs
1 week ago
RemeGen Biosciences, Inc. South San Francisco, United StatesORGANIZATION · RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep ins ...
-
Senior Director, Regulatory Affairs
4 days ago
Hibio South San Francisco, United StatesJOB TITLE: Senior Director, Regulatory Affairs · DEPARTMENT: Regulatory Affairs · TYPE: Full-Time · HI-Bio, Inc. is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediate ...
-
Global Director of Regulatory Affairs
4 days ago
Remegen Biosciences, Inc. South San Francisco, United StatesJob Description · Job DescriptionORGANIZATION · RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Mary ...
-
Regulatory Affairs Specialist(W2 Only)
1 day ago
Infosoft Teksolutions Palo Alto, United StatesHere are the job position details for your review: · Job Title**:Regulatory Affairs Specialist (W2 Only)** · Pay Rate**:$63 to $68.89/HR** · Duration**:12 months** · Location**:Palo Alto, CA (Hybrid - 2 days/week onsite)** · **Must have skills on the Resume**: · - **Product Regis ...
-
Regulatory Affairs
3 days ago
Entegee Hercules, United StatesJob Description · Job DescriptionSummary: Seeking a Regulatory Affairs Specialist with 2-5 years of experience in the IVD industry, to provide regulatory support for product transitions from IVDD to IVDR, ensuring compliance and assisting in documentation and labeling updates. Th ...
-
Cytokinetics South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
Senior Director, CMC Regulatory Affairs - South San Francisco, United States - Allogene Therapeutics
Description
Job Description
About Allogene:
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please 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 quality, manufacturing/tech ops and supply chain teams. Reporting to the Head of Regulatory Affairs, this individual will be responsible for assuring the CMC regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and high quality.
We encourage applicants who believe they have the skills and drive to succeed at Allogene to apply for this role.
Responsibilities include, but are not limited to:
As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.
#LI-EL1