Summer External Associate - US Regulatory Policy & Intelligence
Novartis, Rockville, MD, United States
Summer External Associate – U.S. Regulatory Policy & Intelligence – Rockville, MD (Local Candidates Only)
Temporary contractor opportunity with Novartis through Magnit Global, two‑month internship, aimed at students seeking flexibility and new skill development.
Job Description Our U.S. Regulatory Affairs & Policy team translates evolving FDA and legislative environments into clear, practical guidance for development and leadership decision‑making. This internship offers hands‑on experience analyzing regulatory policy signals and precedents and turning them into insights that can shape U.S. regulatory strategy.
Responsibilities
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.
Minimum Requirements
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 & Compensation Rockville, MD (Hybrid; local candidates only). Pay rate: $24/hour. Contract: 2‑month W2 (based on education and experience). Benefits: Health, dental, vision, 401(k).
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 For reasonable accommodation during application, interviewing, or pre‑employment testing, please contact Magnit at directsourceproteam@prounlimited.com.
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Job Description Our U.S. Regulatory Affairs & Policy team translates evolving FDA and legislative environments into clear, practical guidance for development and leadership decision‑making. This internship offers hands‑on experience analyzing regulatory policy signals and precedents and turning them into insights that can shape U.S. regulatory strategy.
Responsibilities
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.
Minimum Requirements
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 & Compensation Rockville, MD (Hybrid; local candidates only). Pay rate: $24/hour. Contract: 2‑month W2 (based on education and experience). Benefits: Health, dental, vision, 401(k).
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 For reasonable accommodation during application, interviewing, or pre‑employment testing, please contact Magnit at directsourceproteam@prounlimited.com.
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