Sr. Manager/Associate Director, Regulatory Affairs, CMC San Francisco, CA/Hybrid
Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR.
We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR.
Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.
BridgeBio is a biopharmaceutical company founded todiscover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseasesand cancers with clear genetic drivers.
We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients.
Founded in 2015, the company has built a portfolio of 30
drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aims to translate today's discoveries into tomorrow's medicines.
We have U.
S.
offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country.
We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.
This regulatory professional will have demonstrated the ability to work independently under the direction of his/her manager.
This individual will manage internal regulatory processes, and prepare documents for regulatory submissions in compliance with global health authority regulations.
In conjunction with regulatory affairs leadership, he/she will develop strong relationships, collaborate, and interact with various departments and levels of management, including interactions across BridgeBio subsidiaries.
Furthermore, the successful candidate will have demonstrated knowledge of regulatory requirements and guidelines and be able to apply their knowledge to daily work, and as needed represent regulatory affairs CMC as part of an interdisciplinary team.
Responsibilities Develop global CMC regulatory strategies in collaboration with manager and CMC subject-matter-experts to meet business objectives for Bridgebio Cardio-renal programs Collaborate with cross-functional teams to create and prepare CMC sections of regulatory dossiers, including global IMPD/IND and marketing applications (FDA, EMA, other) Prepare and communicate timelines Plan and coordinate preparation of the CMC sections Manage the author, review, and approval workflows Provide recommendations to the team on regulatory strategy as needed Provide RA CMC support for Health Authority interactions, including coordination of drafting and review of meeting requests and briefing books Work with team on strategy and responses to Health Authority CMC questions (FDA, EMA, other) Provide support from triage through finalization of regulatory responses Provide input to the team on regulatory strategy as needed Provide regulatory assessments for CMC changes, and plan regulatory submissions as needed, e.
g.
, amendments supporting revisions to IMPD/IND, supplements/variations to marketing applications Support archival activities of RA CMC submissions, including amendments to IMPD/IND, post-approval submissions to marketing applications, Health Authority correspondence, and regulatory CMC commitments As needed, may be delegated responsibilities such as participating in CMC sub-teams as RA CMC lead Attend CMC/cross-functional team meetings representing RA CMC Maintain current knowledge of applicable global regulations, guidance, and standards for drug development and product registration Other duties as assigned No matter your role at BridgeBio, successful team members are:
Patient Champions, who put patients first and uphold strict ethical standards Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset Truth Seekers, who are detailed, rational, and humble problem solvers Individuals Who Inspire Excellence in themselves and those around them High-quality executors, who execute against goals and milestones with quality, precision, and speed Education, Experience & Skills Requirements A minimum of a bachelor's degree is required (life sciences discipline preferred) Minimum of 5 years experience in pharmaceutical or related industry in regulatory affairs, CMC, or related function, e.
g.
, drug development/manufacturing/QC/QA (an equivalent combination of education and experience may be considered) Excellent communication skills and attention to detail Able to manage projects and deliver output in a timely manner under the direction of the manager Excellent computer skills, e.
g.
, Microsoft suite of applications/software and document management systems such as Veeva What We Offer Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts A culture inspired by our values:
put patients first, think independently, be radically transparent, every minute counts, and let the science speak An unyielding commitment to always putting patients first.
Learn more about how we do this here A de-centralized model that enables our program teams to focus on advancing science and helping patients.
Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science A place where you own the vision - both for your program and your own career path A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game Access to learning and development resources to help you get in the best professional shape of your life Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) Flexible PTO Rapid career advancement for strong performers Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time Partnerships with leading institutions Commitment to Diversity, Equity & Inclusion $158,000 - $212,000 a year At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.
The anticipated salary range for candidates for this role who will work in California is $158,000 to $212,000/year.
The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, and performance during the interview process.
BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
To view San Francisco County's Fair Chance Ordinance, please click here.
#J-18808-Ljbffr Recommended Skills Assessments Attention To Detail Business Planning Communication Document Management Systems Drug Development Estimated Salary: $20 to $28 per hour based on qualifications.
We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR.
Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.
BridgeBio is a biopharmaceutical company founded todiscover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseasesand cancers with clear genetic drivers.
We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients.
Founded in 2015, the company has built a portfolio of 30
drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aims to translate today's discoveries into tomorrow's medicines.
We have U.
S.
offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country.
We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.
This regulatory professional will have demonstrated the ability to work independently under the direction of his/her manager.
This individual will manage internal regulatory processes, and prepare documents for regulatory submissions in compliance with global health authority regulations.
In conjunction with regulatory affairs leadership, he/she will develop strong relationships, collaborate, and interact with various departments and levels of management, including interactions across BridgeBio subsidiaries.
Furthermore, the successful candidate will have demonstrated knowledge of regulatory requirements and guidelines and be able to apply their knowledge to daily work, and as needed represent regulatory affairs CMC as part of an interdisciplinary team.
Responsibilities Develop global CMC regulatory strategies in collaboration with manager and CMC subject-matter-experts to meet business objectives for Bridgebio Cardio-renal programs Collaborate with cross-functional teams to create and prepare CMC sections of regulatory dossiers, including global IMPD/IND and marketing applications (FDA, EMA, other) Prepare and communicate timelines Plan and coordinate preparation of the CMC sections Manage the author, review, and approval workflows Provide recommendations to the team on regulatory strategy as needed Provide RA CMC support for Health Authority interactions, including coordination of drafting and review of meeting requests and briefing books Work with team on strategy and responses to Health Authority CMC questions (FDA, EMA, other) Provide support from triage through finalization of regulatory responses Provide input to the team on regulatory strategy as needed Provide regulatory assessments for CMC changes, and plan regulatory submissions as needed, e.
g.
, amendments supporting revisions to IMPD/IND, supplements/variations to marketing applications Support archival activities of RA CMC submissions, including amendments to IMPD/IND, post-approval submissions to marketing applications, Health Authority correspondence, and regulatory CMC commitments As needed, may be delegated responsibilities such as participating in CMC sub-teams as RA CMC lead Attend CMC/cross-functional team meetings representing RA CMC Maintain current knowledge of applicable global regulations, guidance, and standards for drug development and product registration Other duties as assigned No matter your role at BridgeBio, successful team members are:
Patient Champions, who put patients first and uphold strict ethical standards Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset Truth Seekers, who are detailed, rational, and humble problem solvers Individuals Who Inspire Excellence in themselves and those around them High-quality executors, who execute against goals and milestones with quality, precision, and speed Education, Experience & Skills Requirements A minimum of a bachelor's degree is required (life sciences discipline preferred) Minimum of 5 years experience in pharmaceutical or related industry in regulatory affairs, CMC, or related function, e.
g.
, drug development/manufacturing/QC/QA (an equivalent combination of education and experience may be considered) Excellent communication skills and attention to detail Able to manage projects and deliver output in a timely manner under the direction of the manager Excellent computer skills, e.
g.
, Microsoft suite of applications/software and document management systems such as Veeva What We Offer Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts A culture inspired by our values:
put patients first, think independently, be radically transparent, every minute counts, and let the science speak An unyielding commitment to always putting patients first.
Learn more about how we do this here A de-centralized model that enables our program teams to focus on advancing science and helping patients.
Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science A place where you own the vision - both for your program and your own career path A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game Access to learning and development resources to help you get in the best professional shape of your life Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) Flexible PTO Rapid career advancement for strong performers Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time Partnerships with leading institutions Commitment to Diversity, Equity & Inclusion $158,000 - $212,000 a year At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.
The anticipated salary range for candidates for this role who will work in California is $158,000 to $212,000/year.
The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, and performance during the interview process.
BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
To view San Francisco County's Fair Chance Ordinance, please click here.
#J-18808-Ljbffr Recommended Skills Assessments Attention To Detail Business Planning Communication Document Management Systems Drug Development Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
