Northeastern University
Dompe-Postdoctoral Research Fellow, Global Regulatory Affairs
Northeastern University, San Jose, California, United States, 95199
Dompe-Postdoctoral Research Fellow, Global Regulatory Affairs
About the Opportunity
Northeastern University Pharmaceutical Industry Fellowship Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.D. graduates. A key element of the program’s success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry. Fellows have the opportunity to work closely with our innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities. In partnership with Northeastern University, Dompe is offering a two-year Global Regulatory Affairs fellowship, based Remote with the option to relocate to San Mateo, CA.
Responsibilities The PharmD fellow will gain hands‑on training in global drug development and regulatory strategy. Over two years, the fellow will support submission of industry’s regulatory new drug applications (INDs, CTAs, NDAs/BLAs), labeling, and health authorities’ interactions, while collaborating with cross‑functional teams across Clinical, Safety and CMC. The program also includes a six‑month rotation in Commercial Regulatory Affairs, providing exposure to advertising, promotion, and labeling compliance.
Regulatory Strategy and Submissions
Contribute to the preparation and review of regulatory submissions (INDs, CTAs, NDAs/BLAs, orphan drug applications, pediatric study plans).
Support drafting of regulatory briefing documents and responses to Health Authorities.
Participate in health authority meetings under mentorship (FDA, EMA, PMDA, etc.).
Labeling & Core Documentation
Assist in the development and maintenance of core regulatory documents (Investigator’s Brochure, study protocols, Informed Consent Forms, product labeling).
Support global labeling activities, including updates to Company Core Data Sheet (CCDS), US Prescribing Information, and EU SmPC.
Cross‑Functional Collaboration
Work closely with Clinical Development, Drug Safety, CMC teams to ensure regulatory alignment across programs.
Participate in project team meetings and contribute a regulatory perspective to development strategies.
Commercial Regulatory Rotation (6 months)
Review advertising and promotional materials to ensure compliance with FDA and global regulations.
Collaboration with cross‑functional Promotional Review Committees (PRC/MLR).
Gain experience with regulatory requirements for promotional labeling and digital/social media campaigns.
Compliance & Regulatory Intelligence
Conduct regulatory intelligence to track evolving FDA/EMA/ICH guidance and competitor activity.
Support inspection readiness and contribute to internal process improvements.
Professional Development & Academic Engagement
Engage in seminars, research, and teaching opportunities through Northeastern University.
Present fellowship learnings at professional conferences or internal forums.
Develop leadership, communication, and project management skills under the mentorship of experienced regulatory leaders.
Qualifications
Doctor of Pharmacy degree from an ACPE‑accredited institution.
Eligible for pharmacist licensure in the State of Massachusetts.
Excellent oral and written communication skills.
Strong time management and leadership abilities.
Ability to work independently and take initiative on a variety of projects at both the industry site and Northeastern.
Understanding of drug development, clinical research and regulatory processes.
Familiarity with FDA, EMA, and ICH guidelines.
Interest in Regulatory Affairs, advertising and promotion and labeling compliance for pharmaceuticals.
Skills
Strong written and verbal communication skills for regulatory documents and cross‑functional discussions.
Analytical and critical thinking skills to evaluate data and regulatory requirements.
Project management and organizational skills, including the ability to manage multiple tasks.
Proficiency in Microsoft Office (Word, PowerPoint, Excel); ability to quickly learn regulatory systems/tools.
Abilities
Ability to work collaboratively in cross‑functional teams and adapt in a fast‑paced, global environment.
Ability to interpret complex scientific and clinical data and translate into regulatory strategy.
Ability to maintain attention to details and ensure accuracy in regulatory documentation.
Ability to exercise professionalism, integrity and confidentiality when handling sensitive information.
Ability to take initiative, seek mentorship, and grow into an independent regulatory professional.
Additional Information Applicants should submit the following application materials by the priority deadline of October 31, 2025:
Curriculum vitae (CV).
Unofficial PharmD transcripts.
Cover letter.
Three formal letters of recommendation (LORs) should be sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 21, 2025. LOR writers must include the candidate’s name and the fellowship program(s) in the subject line (e.g., Smith, John – Alnylam, GSK). Address Cover Letter And Letters Of Recommendation To J. Andrew Orr‑Skirvin, PharmD, BCOP
Clinical Professor, Department of Pharmacy & Health Systems Sciences
Pharmaceutical Industry Fellowship Program Director
360 Huntington Ave, 140 The Fenway R218
Boston, MA 02115
Position Type Research
Benefits 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. Northeastern University 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.
Compensation Grade/Pay Type 108S
Expected Hiring Range $65,360.00 - $92,322.50
EEO Statement 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.
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Responsibilities The PharmD fellow will gain hands‑on training in global drug development and regulatory strategy. Over two years, the fellow will support submission of industry’s regulatory new drug applications (INDs, CTAs, NDAs/BLAs), labeling, and health authorities’ interactions, while collaborating with cross‑functional teams across Clinical, Safety and CMC. The program also includes a six‑month rotation in Commercial Regulatory Affairs, providing exposure to advertising, promotion, and labeling compliance.
Regulatory Strategy and Submissions
Contribute to the preparation and review of regulatory submissions (INDs, CTAs, NDAs/BLAs, orphan drug applications, pediatric study plans).
Support drafting of regulatory briefing documents and responses to Health Authorities.
Participate in health authority meetings under mentorship (FDA, EMA, PMDA, etc.).
Labeling & Core Documentation
Assist in the development and maintenance of core regulatory documents (Investigator’s Brochure, study protocols, Informed Consent Forms, product labeling).
Support global labeling activities, including updates to Company Core Data Sheet (CCDS), US Prescribing Information, and EU SmPC.
Cross‑Functional Collaboration
Work closely with Clinical Development, Drug Safety, CMC teams to ensure regulatory alignment across programs.
Participate in project team meetings and contribute a regulatory perspective to development strategies.
Commercial Regulatory Rotation (6 months)
Review advertising and promotional materials to ensure compliance with FDA and global regulations.
Collaboration with cross‑functional Promotional Review Committees (PRC/MLR).
Gain experience with regulatory requirements for promotional labeling and digital/social media campaigns.
Compliance & Regulatory Intelligence
Conduct regulatory intelligence to track evolving FDA/EMA/ICH guidance and competitor activity.
Support inspection readiness and contribute to internal process improvements.
Professional Development & Academic Engagement
Engage in seminars, research, and teaching opportunities through Northeastern University.
Present fellowship learnings at professional conferences or internal forums.
Develop leadership, communication, and project management skills under the mentorship of experienced regulatory leaders.
Qualifications
Doctor of Pharmacy degree from an ACPE‑accredited institution.
Eligible for pharmacist licensure in the State of Massachusetts.
Excellent oral and written communication skills.
Strong time management and leadership abilities.
Ability to work independently and take initiative on a variety of projects at both the industry site and Northeastern.
Understanding of drug development, clinical research and regulatory processes.
Familiarity with FDA, EMA, and ICH guidelines.
Interest in Regulatory Affairs, advertising and promotion and labeling compliance for pharmaceuticals.
Skills
Strong written and verbal communication skills for regulatory documents and cross‑functional discussions.
Analytical and critical thinking skills to evaluate data and regulatory requirements.
Project management and organizational skills, including the ability to manage multiple tasks.
Proficiency in Microsoft Office (Word, PowerPoint, Excel); ability to quickly learn regulatory systems/tools.
Abilities
Ability to work collaboratively in cross‑functional teams and adapt in a fast‑paced, global environment.
Ability to interpret complex scientific and clinical data and translate into regulatory strategy.
Ability to maintain attention to details and ensure accuracy in regulatory documentation.
Ability to exercise professionalism, integrity and confidentiality when handling sensitive information.
Ability to take initiative, seek mentorship, and grow into an independent regulatory professional.
Additional Information Applicants should submit the following application materials by the priority deadline of October 31, 2025:
Curriculum vitae (CV).
Unofficial PharmD transcripts.
Cover letter.
Three formal letters of recommendation (LORs) should be sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 21, 2025. LOR writers must include the candidate’s name and the fellowship program(s) in the subject line (e.g., Smith, John – Alnylam, GSK). Address Cover Letter And Letters Of Recommendation To J. Andrew Orr‑Skirvin, PharmD, BCOP
Clinical Professor, Department of Pharmacy & Health Systems Sciences
Pharmaceutical Industry Fellowship Program Director
360 Huntington Ave, 140 The Fenway R218
Boston, MA 02115
Position Type Research
Benefits 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. Northeastern University 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.
Compensation Grade/Pay Type 108S
Expected Hiring Range $65,360.00 - $92,322.50
EEO Statement 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.
#J-18808-Ljbffr