Intern Regulatory Affairs

LanceSoft Inc

Durham, NC

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JOB DETAILS

JOB TYPE

Temporary

SKILLS

Biotech and Pharmaceutical, Clinical Medicine, Communication Skills, Cross-Functional, Department of Health and Human Services, Detail Oriented, Documentation, Drug Development, English Language, FDA (Food and Drug Administration), GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Gene Therapy, ICH Regulations, Information Technology & Information Systems, International Health, Maintain Compliance, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Organizational Skills, Presentation/Verbal Skills, Product Development, Project/Program Management, Regulations, Regulatory Submissions, Strategic Planning, Writing Skills

LOCATION

Durham, NC

POSTED

30+ days ago

The Regulatory Affairs Internship provides graduate students with the opportunity to apply academic training to real world challenges in the rapidly evolving field of cell and gene therapy. Working within a cross functional regulatory team, the intern supports activities that ensure compliance with global health authority requirements while contributing to the advancement of transformative therapies for patients. Job Responsibilities: Support the preparation, review, and organization of regulatory submissions, including original INDs/CTAs and amendments, health authority briefing packages and information requests/responses, and CMC documentation. Apply regulatory science principles learned in coursework to evaluate guidance documents, regulatory precedents, and emerging policies relevant to advanced therapy medicinal products (ATMPs). Assist in developing regulatory strategies for early-stage and clinical-stage cell and gene therapy programs. Participate in cross-functional meetings with Quality, CMC, Clinical, Translational Medicine, and Program Management teams to understand how regulatory considerations shape product development. Identify challenges in regulatory processes or documentation workflows and propose practical, well-reasoned solutions. Contribute to internal regulatory intelligence efforts by summarizing new FDA, EMA, and ICH updates and assessing their impact on ongoing programs. Observe and document the organization’s culture, structure, and decision-making processes, including interactions with internal stakeholders and external partners. Engage with regulatory professionals and subject matter experts to gain mentorship, career guidance, and insight into industry best practices. Participate in networking opportunities, team events, and professional development sessions to build connections across the organization. Support with Regulatory Submission and other Regulatory Operations related activities Minimum Requirements: Currently enrolled in a Masters of Pharmaceutical Sciences Regulatory Sciences Program with at least one semester of coursework completed Strong understanding of drug development processes and regulatory frameworks Basic understanding of Health and Human Services (HHS), and Food and Drug Administration (FDA) Excellent English written and verbal communication skills Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) Strong attention to detail and organizational skills Ability to work both independently and collaboratively in a team environment Demonstrated interest in cell and gene therapy or biologics regulation Preferred Education, Experience and Skills: Previous internship or work experience in pharmaceutical, biotech, or regulatory environments Knowledge of FDA and ICH guidelines relevant to biologics and advanced therapies Understanding of GMP, GCP, GLP, and quality systems Experience with regulatory information management systems

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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