Regulatory Affairs Director: Strategy & Submissions

BioCryst Pharmaceuticals, Inc.; United States; On-site; USD 130,000 - 180,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director of Regulatory Affairs to manage regulatory submission strategies and ensure compliance with US FDA regulations. This role requires a Bachelor's degree in a scientific discipline, with preferred advanced degrees and at least 10 years of relevant experience. Key responsibilities include overseeing regulatory submissions for new products and maintaining relationships with regulatory authorities. Strong interpersonal and communication skills are essential for success in this position.

Qualifications

• Bachelor's degree required with 10+ years of experience in regulatory affairs.
• Ability to maintain high ethical standards.
• Thorough knowledge of US FDA regulations.

Responsibilities

• Support regulatory strategies for on-time submission and approval of products.
• Manage US regulatory submissions, including INDs, NDAs, and other filings.
• Lead activities associated with the development of Company Core Data Sheet.

Skills

Regulatory affairs expertise

Strong decision-making skills

Interpersonal skills

Effective communication

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PhD, PharmD, MD)

Tools

MS Word

MS PowerPoint

MS Excel

Job description

A leading biopharmaceutical company is seeking a Director of Regulatory Affairs to manage regulatory submission strategies and ensure compliance with US FDA regulations. This role requires a Bachelor's degree in a scientific discipline, with preferred advanced degrees and at least 10 years of relevant experience. Key responsibilities include overseeing regulatory submissions for new products and maintaining relationships with regulatory authorities. Strong interpersonal and communication skills are essential for success in this position.