Job Details

Dompe-Postdoctoral Research Fellow, Global Regulatory Affairs

Position Number: 6649920
Location: San Jose, CA
Position Type: Medicine - Other Medicine

Dompe-Postdoctoral Research Fellow, Global 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 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 .

About Dompe

Dompe is an Italian bio-pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand-in-hand with a commitment to research and development to meet unsatisfied therapeutic needs. Established in 1940 in Milan, Dompe has an industrial and biotech research hub in L'Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompe are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).

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 6-month rotation in Commercial Regulatory Affairs, providing exposure to advertising, promotion, and labeling compliance. Conducted in partnership with Northeastern University, the fellowship blends industry experience and academic engagement to prepare fellows for impactful careers in Regulatory Affairs.

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:

1. Curriculum vitae (CV), uploaded
2. Unofficial PharmD transcripts, uploaded
3. Cover letter, uploaded

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

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.

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.

Compensation Grade/Pay Type:
108S

Expected Hiring Range:
$65,360.00 - $92,322.50

With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role. Salary ranges are reviewed regularly and are subject to change.

To apply, visit https://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/San-Jose-CA/Dompe-Postdoctoral-Research-Fellow--Global-Regulatory-Affairs_R136643