Job Description Summary
#LI-Hybrid
Job Description
Major Accountabilities
Lead and implement global CMC regulatory strategies for assigned products and projects.
Plan, author, review, and coordinate high‑quality regulatory submissions.
Ensure regulatory compliance, technical accuracy, and alignment with global guidelines.
Identify risks, develop mitigation plans, and communicate key issues to stakeholders.
Collaborate across cross‑functional teams to support product development and lifecycle management.
Lead interactions with health authorities, including preparation and coordination of submissions and responses.
Support due diligence activities for business development opportunities.
Essential Requirements
5+ years of experience in regulatory affairs and/or the pharmaceutical industry.
Understanding of regulatory submission and approval processes.
Knowledge of chemistry, biotechnology, analytics, or pharmaceutical technology, with the ability to evaluate scientific data from a range of disciplines.
Experience working collaboratively in cross‑functional or global teams, with the ability to manage and prioritise multiple activities.
Ability to work independently as well as contribute effectively within team environments.
Strong planning, organisational, and communication skills.
Confidence using digital tools and systems relevant to the role.
Benefits & Rewards
The salary for this position is expected to range between $119,700 and $223,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.
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.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$119,700.00 - $222,300.00
Skills Desired
Change Control, Cross-Functional Teams, Documentation Management, Negotiation Skills, Regulatory Compliance, Risk Assessment, Risk Management, Waterfall ModelDiscover exciting opportunities in sports technology. Join innovative companies transforming the sports industry through data, media, and cutting-edge tech.
Salary: $140000-180000
🤖 This salary estimate is calculated by AI based on the job title, location, company, and market data. Use this as a guide for salary expectations or negotiations. The actual salary may vary based on your experience, qualifications, and company policies.
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