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Postdoctoral Research Fellow, BridgeBio--Regulatory Affairs
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Position Number: 5638472
Location: Boston, MA
Position Type: Health - Healthcare Administration

Postdoctoral Research Fellow, BridgeBio--Regulatory Affairs

About the Opportunity

About the Opportunity:

Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of PharmD graduates. Critical to the success of the program is our ability to prepare Fellows to meet the ongoing workforce needs in various areas of industry.

Our program gives fellows an opportunity to work with our innovative biopharmaceutical industry partners while collaborating with Northeastern University faculty in professional and career development, service, scholarship, and teaching.

In partnership with Northeastern University, BridgeBio is offering a two-year Regulatory Affairs PharmD fellowship based in San Francisco, CA.

About BridgeBio:

BridgeBio Pharma Inc. (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio's pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers, and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible.

BridgeBio exists to bring meaningful medicines to patients as quickly and as safely as possible. We're passionate about fostering open and transparent relationships with patients and their families by staying connected, listening to their experiences, and applying their insights into our work. We hope that by developing these relationships with patients, families, and patient advocacy organizations early in the development phase of our therapies that we can also craft our clinical trial protocols with the patient experience at the forefront.

About Eidos Therapeutics, Inc. a BridgeBio Company

Transthyretin (TTR) amyloidosis (ATTR) is a rare, underdiagnosed, and life-threatening disease with limited treatment options that can damage the heart and/or nervous system. BridgeBio's mission is to improve the morbidity and mortality of patients with ATTR through the discovery and development of a novel therapeutic through its affiliate, Eidos Therapeutics.

Responsibilities:

Regulatory Strategy

Manage, develop, and implement regulatory strategy in support of Eidos development programs.

Support the planning, preparation and execution of high-quality regulatory submissions (e.g. Clinical Trial Application (CTA)/Investigational New Drug (IND) application and amendments, annual reports, initial license applications (New Drug Application (NDA)/Marketing Authorization Application (MAA), etc.) and supplements/variations).

Develop and maintain knowledge of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and other relevant global guidelines to ensure compliance of regulatory strategies and submissions.

Work in cross-functional teams including Clinical, Statistics, Medical Affairs, Commercial, and Nonclinical groups to help operationalize regulatory strategy.

Support regulatory interactions with regulatory bodies including preparation of meeting requests and briefing documents.

Global Labeling

Gain in-depth knowledge of labeling regulations regarding Company Core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), and Structured Product Labeling (SPL).

Support development of regulatory labeling strategy and the negotiation and maintenance of competitive labeling with global health authorities.

Maintain core labeling documents.

Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends and work with cross-functional team to ensure that the regulatory labeling strategy is aligned with the global regulatory strategy.

Assist in preparation of responses to labeling-related queries from health authorities.

Advertising and Promotion

Support regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, health authority regulations, ICH guidelines, Pharmaceutical Research & Manufacturers of Americans (PhRMA) guidelines, company policies and established precedents and recommend revisions/actions that achieve fair balance.

Support the review and approval of promotional and non-promotional materials in a cross-functional promotional review committee that includes Commercial, Medical Affairs, and Legal.

Coordinate timely and accurate review of materials for submission to the United States Food and Drug Administration (FDA).

Qualifications:

Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.

Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at the industry site and Northeastern.

Additional Information:

Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31st, 2024.

Curriculum vitae (CV), uploaded

Unofficial PharmD transcripts, uploaded

Cover letter, uploaded

Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 22nd, 2024. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - Alnylam, GSK).

Address cover letter and three LORs to:

J. Andrew Orr-Skirvin, PharmD, BCOP

Clinical Professor, School of Pharmacy

Chair, Department of Pharmacy & Health System Sciences

Director of Pharmaceutical Industry Fellowship Program

360 Huntington Ave, 140TF R218

Boston, MA 02115

Position Type

Research

Additional Information

Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.

Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.

Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.

All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.

To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.

To apply, visit https://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/Boston-MA-Main-Campus/Postdoctoral-Research-Fellow--BridgeBio--Regulatory-Affairs_R127614