Director/Sr. Director/Executive Director, Clinical Regulatory Affairs

• Integrate scientific, medical and regulatory perspectives to drive development of innovative global regulatory strategies to achieve rapid approvals for investigational and marketing plans from agencies such as FDA, EMA, PMDA, NMPA (CHN)
• Perform research to drive development of regulatory strategy for the assigned clinical development program
• Lead and drive the preparation for Agency meetings and associated briefing document preparation
• Lead and manage queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
• Lead representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
• Own/drive the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
• Maintain knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
• Exercise discretion, demonstrate integrity and independent judgment in the performance of the duties described above

• Must possess excellent scientific/analytical thinking abilities, written and verbal communication skills along with an advanced degree such as Ph.D.
• A minimum of 5 years of prior pharmaceutical industry experience (preferably in novel biologic/ADC based oncology drug development) at least 3 of which should include global regulatory strategy experience.
• A solution centric mindset with a drive to learn/grow, thrive in a fast-paced small company environment along with prior experience working in cross-company joint development collaboration settings would be highly desired.

• Deep and comprehensive understanding of US FDA, ICH and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Prior experience in working with collaborating sponsors across companies, geographic regions including China in novel oncology product development  
• High attention to detail; ability to coordinate and prioritize assigned projects according to corporate goals
• Strong basic science/clinical/medical foundation and interpersonal skills both written and verbally

The expected base salary range for this role is 200,000 to 300,000 annually, with final base salary determined by the level at which a candidate is hired. Actual compensation will reflect multiple factors, including qualifications, experience, and skill set.