Regulatory Affairs Leader

Regulatory Affairs Leader

Join the Adventure!

CAMP4 is looking for a Director / Senior Director of Regulatory Affairs who can apply their knowledge of global regulations governing pharmaceutical drug development to all aspects of CAMP4’s manufacturing, preclinical and clinical drug and device development programs, policies, and procedures. This person is highly-collaborative, creative and self-starting and thrives in a dynamic & fast-paced environment. They are an experienced, hands-on professional ready to embrace the challenge of establishing a department from the ground up. Playing a key role in the organization, this individual will be providing regulatory support for multiple clinical and pre-clinical project teams. This position will report to the Chief Medical Officer.

Primary Responsibilities

• Manage the planning, preparation, submission, and maintenance of INDs, IMPDs, NDAs, BLAs, MAAs, Orphan Drug Applications, Pediatric Investigational Plans, and other regulatory submissions as appropriate, with initial focus on the early stages of clinical development

• Lead Regulatory sub-teams by providing strategic guidance across the different clinical programs to write, critically review, and ultimately obtain Health Authority approvals

• Function as the primary liaison with FDA and other regulatory agencies

• Continually monitor newly published FDA guidelines and international guidance documents with respect to our multiple current and future development programs & provide training on applicable requirements for scientific & clinical staff as required

• Manage external Regulatory services vendors (publishing, CMC...)

• Serves as a subject matter expert on Regulatory Affairs processes across the product portfolio.

• Advises program leaders with relevant expertise where needed.

Qualifications and Experience

• A minimum of 8 years of pharmaceutical industry experience, at least 5 of which should include regulatory duties

• Direct experience in initiating and conducting successful interactions within FDA or other Health Authorities.

• Demonstrated success leading a regulatory team in the preparation of pre-IND, IND, pre-NDA, NDA and other regulatory reports and documents.

• Strong global experience and knowledge of US and global regulatory requirements and guidelines for US FDA, EU EMA and other global health authorities.