Regulatory Affairs Manage

About the Role

As our Regulatory Affairs Manager, you will play a crucial role in guiding our innovative therapies through the complex regulatory landscape. You'll be responsible for developing and implementing global regulatory strategies to support our product pipeline from early development through commercialization.

Key Responsibilities

• Develop and execute regulatory strategies for multiple development programs
• Prepare and manage regulatory submissions (INDs, NDAs, BLAs, MAAs) to FDA, EMA, and other health authorities
• Serve as primary liaison with regulatory agencies, including organizing and participating in meetings
• Provide regulatory guidance to cross-functional teams throughout product development
• Ensure compliance with evolving regulations and guidelines
• Manage and mentor junior regulatory affairs staff

Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, or related field
• 7+ years of progressive regulatory affairs experience in biotechnology, with focus on biologics/advanced therapies
• In-depth knowledge of FDA and EMA regulations and guidelines
• Experience preparing and submitting INDs, BLAs/NDAs, and MAAs
• Strong project management and leadership skills
• Excellent written and verbal communication abilities

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.