The Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development teams and the RA Department in all aspects of global regulatory affairs related to development of novel oncology therapeutics (multiple modalities such as ADCs, bispecific antibodies and T-cell engagers etc.). The primary area of focus is global regulatory aspects of preclinical and clinical areas of Oncology drug development and the policies/procedures required to ensure compliance with global HA regulations.

The level for this role could range across Director/Sr. Director/Exec Director based on the demonstrated expertise, prior Oncology regulatory experience and global regulatory agency experiences (successful BLA/MAA filings) including label negotiations of the interested candidate. Prior experience of working across partner companies in a collaborative setting is highly desired. Leadership, temperament, and attention to details to drive data-informed decision making in a fast-paced setting along with the ability to toggle between "player/coach roles" as needed are strongly desired.

Responsibilities

• 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

Qualifications

• 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.

The following attributes are strongly 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

Compensation and Benefits:
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.

SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.