Regulatory Affairs Strategist
3 days ago
Position Overview
We are seeking a highly experienced Regulatory Affairs Strategist to drive regulatory strategy for our anti-infective portfolio through all development phases.
This role involves co-leading a US NDA with a cross-functional project team and serving as the primary liaison with the FDA. The ideal candidate will have strong communication, leadership, and team collaboration abilities and experience working in a remote setting.
Key Responsibilities
- Lead US NDA submissions, including FDA interactions and dossier preparation.
- Ensure post-approval regulatory compliance and oversee all FDA submissions for assigned products.
- Develop and implement clinical regulatory strategies; support risk mitigation and contribute to due diligence assessments.
- Provide regulatory support for new compounds and line extensions, and act as the primary point of contact for regulatory inquiries.
- Collaborate with internal stakeholders to develop and implement regulatory policies and procedures.
Why This Role?
This is an exceptional opportunity to join our innovative biopharma company and drive regulatory success across our anti-infective portfolio. You will work closely with our cross-functional project team to ensure timely and effective NDA submissions and maintain positive relationships with the FDA.
What We Offer
- A competitive salary of $180,000 - $220,000 per year, based on experience.
- Hybrid work options, allowing you to balance your work and personal life.
- A collaborative and growth-oriented environment that supports your career development and well-being.
- A comprehensive benefits package, including health insurance, retirement savings, and paid time off.
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