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 programs 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

Dompé 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 Dompé has an industrial and biotech research hub in LAquila in addition to branches in Europe (Barcelona Berlin Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompé 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 industrys 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 (Investigators 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 by November 21 2025. LOR writers must include the candidates 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

Additional Information

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

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:

Expected Hiring Range:

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.