Our client is seeking a Sr. Director, Clinical Regulatory Affairs to develop regulatory strategies for both non-clinical and clinical programs and lead interactions with regulatory authorities. Reporting to the SVP, Head of Regulatory Affairs, this role will have significant strategic oversight of various submissions and will be the global regulatory lead for assigned programs for the company.
Responsibilities:
Design and implement regulatory strategies for clinical trial applications
Oversee, create and submit regulatory filings for assigned programs
Acting primary representative for all external and internal partnerships, and regulatory communication
Arrange and lead meetings with global health authorities
Qualifications:
Bachelor's degree in Life Sciences or related fields required; advanced degrees such as a PhD in biomedical sciences or related fields preferred.
Minimum of 10 years of experience in the biopharmaceutical industry, with at least 5 years in a regulatory strategy role.
Experience supporting clinical development teams in the autoimmune disease space is a must
Experience in Oncology and Immuno-oncology is preferred but not required
Expertise in regulatory submission structure and content (e.g. IND, CTA, MAA, NDA, BLA)
Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies