Head Of Regulatory Affairs

We are seeking a talented Head of Regulatory Affairs to join our exciting organization based in Los Angeles, CA. As the Head of Regulatory Affairs, you will play a critical role in ensuring that our products comply with FDA, EMA, and other global regulatory requirements. You will be responsible for preparing and maintaining CMC documentation for various applications, including NDAs, DMFs, CEPs, and INDs. In addition, you will manage a team of Regulatory Affairs professionals and collaborate with internal and external stakeholders to ensure timely and effective submissions.

Responsibilities:

• Lead and manage a team of Regulatory Affairs professionals to ensure that projects are completed on time, with high quality, and within budget
• Participate in the development and implementation of regulatory strategies to support product approvals, license maintenance, and lifecycle management
• Prepare and maintain CMC documentation for various applications, including NDAs, DMFs, CEPs, INDs, etc.
• Collaborate with cross-functional teams to ensure that regulatory requirements are integrated into product development plans and timelines
• Keep up to date with FDA, EMA, and other global agencies' regulations related to CMC submissions for generics and NCEs
• Write technical/regulatory texts and communicate with regulatory authorities to resolve issues and advance submissions

Requirements:

• At least 8 years of experience working in Regulatory Affairs CMC or a related field, with a track record of successful submissions and approvals
• Bachelor's degree in Chemistry or other related sciences
• Strong knowledge of FDA, EMA, and other global agencies' regulations related to CMC submissions for generics and NCEs
• Proven people management experience, with a track record of building and leading high-performing teams
• Excellent writing, communication, and interpersonal skills

We offer a dynamic work environment, competitive compensation, and benefits packages, and opportunities for professional growth and development. If you are a highly motivated and skilled Regulatory Affairs professional looking for a challenging and rewarding career opportunity, we encourage you to apply.