Postdoctoral Research Fellow, BridgeBio-Regulatory Affairs

About the Opportunity

About the Opportunity:

Northeastern University’s Pharmaceutical Industry Fellowship Program is a two-year fellowship designed to advance the education and training of Pharm.D. graduates in various areas of industry pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas. The program is a collaboration between Northeastern University and biopharmaceutical industry partners.

Our program provides a dynamic academic environment offering fellows the opportunity for a wide breadth of experiences:

• Develop teaching skills through participation in our Teaching and Learning Seminar series
• Facilitate small and large group didactic education in partnership with a faculty mentor
• Create, present, and publish scholarly research through collaborative industry and university relationships
• Engage with faculty who participate in various interdisciplinary
• Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees

In partnership with Northeastern University, Eidos Therapeutics, Inc. a BridgeBio Company is offering a two-year Regulatory Affairs PharmD fellowship based in San Francisco, California.

About Eidos Therapeutics, Inc. a BridgeBio Company

Eidos Therapeutics, Inc. a BridgeBio Company is a clinical-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 product candidate, 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 to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and 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. 

Responsibilities:

The program consists of a 2-year assignment within the Regulatory Affairs team and may be eligible for rotation within another function, eg. Clinical Development, Clinical Operations, and Medical Affairs. The PharmD Fellow will remote and work on-site and at Eidos Therapeutics, Inc. a BridgeBio Company in San Francisco, CA.

Regulatory Strategy Primary Objectives

• 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. CTA/IND and amendments, annual reports, initial license applications (NDA/MAA, etc.) and supplements/variations) 
• Develop and maintain knowledge of ICH, GCP, 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 Primary Objectives
• 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 Promotions Primary Objectives

• Support regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, health authority regulations, ICH guidelines, 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 FDA
• Support regulatory reviewer for the promotional review committee to ensure regulatory compliance for all communications

Qualifications:

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

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

Preferred Qualifications:

• Strong interest in pursuing a career at Eidos and BridgeBio
• Strong verbal, written communication, interpersonal, listening, and organizational skills 
• Ability to work in a diverse environment
• Demonstrated ability to adapt to changing priorities and work effectively
• Sense of urgency and perseverance to achieve results
• Unquestionable ethics, and professional integrity

Additional Information:

Applications are accepted on a rolling basis.

• Curriculum vitae (CV), uploaded
• Unofficial PharmD transcripts, uploaded
• Cover letter, uploaded

Three formal letters of recommendation (LORs) sent directly from the letter writer to [email protected] by December 1st, 2023. 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

The expected hiring rate is $66,560 to 83,335 based on the position's responsibilities and scope.

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 .