SystImmune · 1 month ago
Director/Sr. Director/Executive Director, Clinical Regulatory Affairs
Princeton, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$200K/yr - $300K/yr
5+ years expSystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. The Regulatory Affairs role will drive regulatory strategy and execution within project development teams, focusing on global regulatory aspects of oncology drug development and ensuring compliance with global health authority regulations.
BiopharmaBiotechnologyProfessional Services
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
Qualification
Required
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
Preferred
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
Benefits
100% paid employee premiums for medical/dental/vision
STD
LTD
A 401(k) plan with a 50% company match of up to 3%
A vesting schedule of only 5 years
15 PTO days per year
Sick leave
11 paid holidays
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Company
SystImmune
SystImmune is a biotechnology company.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Martin S. Olivo, MD, MSc,
Chief Medical Officer
Recent News
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