Global Regulatory Affairs Fellow – Strategy & APL (PharmD)

NU USA Northeastern University; Boston (MA); Sur place; USD 60 000 - 85 000; Plein temps

Avantages offerts par ce poste

Benefits package

Résumé du poste

Intellia Therapeutics and Northeastern University jointly offer a 2-year Regulatory Strategy and Advertising/Promotion/Labeling fellowship based in Cambridge, MA. Fellows gain hands-on regulatory experience within Global Regulatory Affairs and collaborate with medical writing, marketing, and regulatory operations teams.

The program emphasizes leadership development, strategic planning, and preparation for regulatory submissions across US and international jurisdictions, with a focus on gene

Qualifications

• PharmD degree from ACPE-accredited institution.
• Eligible for pharmacist licensure in Massachusetts.
• Excellent oral and written communication skills.
• Interest in regulatory affairs and gene editing.

Responsabilités

• Develop regulatory strategies across product development to support marketing authorization.
• Collaborate with cross-functional teams on regulatory filings and communications.
• Assist planning and execution of regulatory submissions for clinical trials and product approvals.
• Lead development of methods to monitor regulatory trends in the US and international jurisdictions.
• Participate in fellowship recruitment activities and interviews.

Connaissances

Communication skills

Scientific acumen

Leadership

Time management

Formation

PharmD degree

Massachusetts licensure eligibility

Description du poste

Intellia Therapeutics and Northeastern University jointly offer a 2-year Regulatory Strategy and Advertising/Promotion/Labeling fellowship based in Cambridge, MA. Fellows gain hands-on regulatory experience within Global Regulatory Affairs and collaborate with medical writing, marketing, and regulatory operations teams.

The program emphasizes leadership development, strategic planning, and preparation for regulatory submissions across US and international jurisdictions, with a focus on gene