Head of Regulatory Affairs & Medical Writing (VP/SVP)

About this role

Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications.Head of Regulatory Affairs & Medical Writing (VP/SVP)Princeton, NJFull TimeRegulatory Affairs & Medical WritingExecutiveShareThe VP/SVP, Head of Regulatory Affairs will provide strategic and operational leadership for the Company’s global regulatory function and serve as a key member of the leadership team. This individual will be responsible for developing and executing global regulatory strategies across the Company’s oncology portfolio, from early development through registration and lifecycle management.

The role will lead interactions with global health authorities, provide regulatory guidance to executive leadership and cross-functional development teams, and build and lead a high-performing Regulatory Affairs and Medical Writing organization.Key ResponsibilitiesGlobal Regulatory Strategy:Develop and execute integrated global regulatory strategies across the Company’s oncology portfolio, from early development and IND-enabling activities through clinical development, registration, commercialization, and lifecycle management. Ensure regulatory strategies are aligned with corporate and product development objectives.Clinical Development Strategy:Provide strategic regulatory guidance on clinical development plans, target product profiles, pivotal trial design, registration pathways, and global development sequencing. Partner closely with Clinical Development, Biostatistics, Clinical Operations, CMC, and other functions to optimize development and registration strategies.Regulatory Submissions & Approvals:Lead and oversee the preparation, submission, and management of major regulatory applications, including INDs, BLAs, MAAs, and other global submissions.

Drive regulatory strategy and execution toward timely approvals across key markets.Health Authority Interactions:Serve as the senior regulatory representative and lead key interactions and negotiations with the FDA, EMA, and other global health authorities, including Pre-IND, End-of-Phase, Type B/C, pre-BLA and other critical regulatory meetings.Regulatory Risk Management & Intelligence:Proactively identify regulatory risks, opportunities, and evolving requirements; develop mitigation strategies and leverage regulatory intelligence and competitive insights to inform development and business decisions.Medical Writing Oversight:Provide strategic oversight of Medical Writing activities to ensure high-quality, scientifically rigorous, and timely regulatory and clinical documentation supporting global development and submissions.Organization & Team Leadership:Build, develop, and lead a high-performing Regulatory Affairs and Medical Writing organization. Establish scalable processes, capabilities, and infrastructure to support the Company’s growing global portfolio while mentoring and developing team members.QualificationsAdvanced degreein life sciences, medicine, pharmacy, or a related field (MD, PhD, PharmD, or equivalent) preferred.15+ years of progressive Regulatory Affairs experiencewithin the biotechnology or pharmaceutical industry, including significant experience in senior leadership roles.Extensive experience in oncology drug development and global regulatory strategyis strongly preferred. Experience with biologics, antibody-drug conjugates (ADCs), bispecific/multispecific antibodies, or other complex therapeutic modalities is highly desirable.Demonstrated track record of leading major regulatory submissions, including INDs and preferably successful BLA/MAA filings and approvals.Extensive experience leading interactions and negotiations with the FDAand other global health authorities, with demonstrated ability to navigate complex regulatory issues and achieve alignment on development and registration strategies.Strong understanding of clinical development, with demonstrated ability to provide strategic regulatory guidance on clinical development plans, pivotal trial design, registration pathways, expedited development programs, and lifecycle management.Demonstrated ability to develop and execute integrated global regulatory strategies across the U.S., Europe, China, and other key markets.Proven experiencebuilding, developing, and leading high-performing Regulatory Affairs teams.Strong scientific and business acumen, with the ability to establish credibility and collaborate effectively with Clinical Development, CMC, Quality, Medical Affairs, Commercial, and other cross-functional stakeholders.Exceptional leadership, communication, influencing, and problem-solving skills, with strong executive presence and the ability to operate effectively in afast-paced, entrepreneurial, and global biotechnology environment.SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, WA and Princeton, NJ.

It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.

We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package.SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.Compensation and Benefits:The expected base salary range for this position is $340,000 - $420,000 annually.

Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills.SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. 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.SystImmune is an Equal Opportunity Employer.

We welcome diverse talent and encourage all qualified applicants to apply.ShareApplyApply for this positionRequiredFirst NameLast NameEmail AddressPhoneAddressResumeWe've received your resume. Clickhereto update it.Attach resumeorPaste resumeAttach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) orPaste resumePaste your resume here orAttach resume fileAre you willing to relocate?No answerYesNoWhat's your citizenship / employment eligibility?No answerI am a U.S. Citizen/Permanent ResidentNon-citizen allowed to work for any employerNon-citizen allowed to work for current employerNon-citizen seeking work authorizationI am a Canadian Citizen/Permanent ResidentOtherLinkedIn Profile URL:Desired salaryTo continue, type the following sentence exactly as written, and also include the last word of the third bullet under Responsibilities in this job posting:“I confirm these responses are my own work and not generated by any AI tool.”Then write the extracted word from the third bullet point in box below. **Tell me about one regulatory decision you personally owned that materially changed a clinical program’s path.

What was the decision, why did you make it, and what happened as a result?Please share a brief summary of your experience in ADC/Antibody/Bispecific oncology studiesThe following questions are entirely optional.To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated.Learn more.GenderDecline to answerFemaleMaleRace/EthnicityDecline to answerHispanic or LatinoWhite, not Hispanic or LatinoBlack or African-American, not Hispanic or LatinoAsian, not Hispanic or LatinoNative Hawaiian or Other Pacific Islander, not Hispanic or LatinoAmerican Indian or Alaskan Native, not Hispanic or LatinoTwo or More Races, not Hispanic or LatinoMENA (Middle Eastern and North African)Human Check*Submit Application