Regulatory Strategy Director

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Formulate and implement regulatory program strategies and contingencies for designated projects.

• Oversee both US and international regulatory teams on assigned initiatives.

• Create and execute innovative strategies to guarantee regulatory success.

• Provide effective regulatory representation for clients and within the organization, acting as a key participant in engagements with the Food and Drug Administration (FDA) and other regulatory bodies.

• Act as the main point of contact and liaison for FDA/EMA/national agencies regarding assigned projects.

• Direct the creation of submissions, which may include INDs, briefing documents, orphan drug applications, breakthrough designations, and NDAs/BLAs/MAAs, among others.

⛳️ Requirements

• A Bachelor’s degree or an international equivalent from an accredited institution in a science or health-related field; a Master’s Degree or PhD is preferred.

• Over 12 years of experience in the CRO, pharmaceutical, biotechnology, or device/diagnostics sectors; an advanced degree may be considered in place of some industry experience.

• 8-9 years of progressive experience in regulatory affairs (US and/or international) within a CRO/biotech/pharma, with at least 4 years served as a consultant.

• Proven experience in interactions with the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory authorities.

• Proven leadership experience in the initiation of INDs and the submission and approval processes for NDAs/BLAs/MAAs.

• Expertise in the drug development process with experience across various phases (early and late stage, post-approval) in multiple therapeutic areas and product types (drugs, biologics, drug-drug combinations, drug-device combination products).

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off