Regulatory Affairs Manager - Pharma (Remote - East Coast Preferred)
A global leader in drug delivery systems is seeking a Regulatory Affairs Manager to support U.S. regulatory activities across multiple business divisions. This role will be instrumental in defining regulatory strategies, ensuring compliance, and maintaining strong engagement with the FDA.
Key Responsibilities:
- Develop and execute U.S. regulatory strategies for product development and market activities.
- Serve as the primary liaison with the FDA, managing regulatory meetings and submissions.
- Ensure compliance with global regulations related to drug delivery systems and combination products.
- Collaborate with cross-functional teams to integrate regulatory requirements into product development.
- Monitor and anticipate U.S. regulatory trends, contributing to the company's regulatory intelligence.
Qualifications:
- Advanced degree in Regulatory Science, Pharmaceutics, or Chemistry.
- Combination produts exp.
- 8+ years of regulatory affairs experience in the pharmaceutical industry, ideally in prescription (RX), injectables, or consumer healthcare.
- Strong knowledge of FDA regulations and experience interacting with regulatory agencies.
- Excellent leadership, strategic thinking, and relationship-building skills.
- Experience in regulatory affairs related to plastics or pharma manufacturing is a plus.
- French language skills are a bonus.
Location: Remote (East Coast preferred) or onsite at a U.S. facility.
If you have a passion for regulatory strategy and a track record of working with the FDA, we'd love to connect!
