Summer External Associate - US Regulatory Policy & Intelligence

:::Please note: This is a temporary contractor opportunity at Novartis :::

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com

Ready to work with/through Magnit at Novartis? Please read on...

Summer External Associate - US Regulatory Policy & Intelligence - Rockville, MD (local candidates only)

Job Description

Our U.S. Regulatory Affairs & Policy team helps translate an evolving FDA and legislative environment into clear, practical guidance for development and leadership decision-making. This summer internship offers hands-on experience analyzing regulatory policy signals and precedents—and turning them into insights that can shape U.S. regulatory strategy.

As a Summer External, you will support the U.S. Regulatory Affairs & Policy function by researching and synthesizing FDA procedural, evidentiary, and leadership-driven policy developments (e.g., filing practices, evidentiary flexibility, expedited programs, and PDUFA-related signals). Working closely with your mentor and key stakeholders, you will build a structured view of emerging trends and provide practical implications for internal regulatory teams.

Your responsibilities include, but are not limited to:

• Conduct landscape reviews of FDA guidance, SOPPs/MAPPs, public communications, advisory committee materials, and relevant legislative/policy signals.
• Develop an annotated timeline of priority U.S. policy developments and “signals” relevant to drug development and approvals.
• Analyze select case examples to map policy posture, procedural posture, evidentiary approach, and outcomes.
• Draft executive-ready summaries (memos, one-pagers, or slides) translating findings into implications for regulatory strategy, submission risk, and FDA engagement.
• Partner with the Regulatory Affairs Policy & Intelligence network to help organize and share learnings for internal stakeholders.

What you’ll bring to the role (Minimum requirements):

• Candidates must be currently enrolled in a U.S. accredited degree-granting college or university pursuing an undergraduate degree.
• Academic focus in life sciences, pharmacy, public health, public policy/health policy, biomedical sciences including chemistry, legal studies or a related field.
• Strong analytical skills with ability to synthesize complex information into clear written outputs.
• Strong communication and collaboration skills; comfort working with cross-functional stakeholders.
• Highly organized with attention to detail and ability to manage multiple workstreams.

Preferred requirements:

• Demonstrated interest in regulatory affairs, FDA policy, drug development, regulatory legislation or regulatory intelligence (coursework, prior internship, or projects).
• Ability to create clear, well-structured slide decks and written summaries (PowerPoint and Word).
• Familiarity with literature searches and navigating public regulatory sources.
• Experience with Excel (or similar tools) to organize information and create simple trackers/tables.

Location: Rockville, MD (Hybrid) (::Local Candidates only::)

Pay Rate: $24/hour (:Rising Sophomore / or Junior Status ONLY:)

(W2 Only - Based On Education And Experience)

Contract: 2-month

Health, dental, vision, 401k

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accommodation:

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.