Careers

SCYNEXIS, Inc. (NASDAQ: SCYX) is a publicly traded biotechnology company dedicated to advancing innovative solutions for severe rare diseases. Our new asset, SCY-770 is being developed for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and has been granted Orphan Drug designation. SCYNEXIS’s proprietary antifungal platform “fungerps” includes BREXAFEMME® (ibrexafungerp tablets), the first approved representative of this novel class, which has been licensed to GSK, and SCY-247 which is currently in a Phase 1 stage of development.

We are seeking a capable, insightful, experienced Senior Director, Regulatory Affairs, to be based in our Jersey City, NJ office. We are committed to positively impacting the lives of patients by developing innovative therapies, come join us and make a difference.

The Senior Director, Regulatory Affairs is responsible for providing subject matter expertise on matters related to global regulatory activities, as well as providing leadership for the growth and responsibilities of the regulatory department. The Senior Director will represent SCYNEXIS in key stakeholder and strategy meetings on regulatory matters related to medical product development and commercialization, including meetings with executive leadership, meetings with the Food and Drug Administration (FDA) and other regulators. This role leads preparation, review, and submission of documents to the FDA and other regulatory authorities to support product development leading to marketing authorization and lifecycle management. This role combines scientific, regulatory, and business knowledge to assure that SCYNEXIS products are developed and distributed according to all applicable regulations in alignment with the company’s strategic goals. The role requires a mastery of medical product regulations to develop efficient solutions to the evolving regulatory needs of the industry.

• Secure US and global regulatory marketing authorization for new products, product updates, and product expansions. This includes preparation and filing of submissions, responding to regulatory authorities and auditors, and leading meetings with regulatory authorities.
• Develop and implement a comprehensive set of policies, processes, and SOPs in support of the organization’s regulatory responsibility.
• Formulate regulatory strategies for pipeline products.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop strategies for resolution.
• Perform global regulatory intelligence including monitoring regulatory updates, workshops, discussions, and other news sources.
• Advance internal awareness of current and upcoming regulations, requirements, and expectations, and identify training and educational needs for the organization.
• Manage processes involved with maintaining annual licenses, registrations, and listings.
• Serve as an internal go-to subject matter expert on regulatory and quality matters.
• Represent the company in external meetings on regulatory matters, including with regulators and auditors and development partners.

• Advanced degree in Life Sciences required (PharmD, PhD, MD, MA)
• 15+ years of progressive experience in regulatory affairs, with increasing scope of responsibility and demonstrated leadership at the global level
• Knowledge of global regulatory agencies/processes/regulations
• Record of successful medical product filings such as INDs, NDAs, BLAs, MAAs
• Excellent writing and oral communication skills, with the ability to convey complex scientific and regulatory concepts clearly and persuasively
• Ability to form and maintain working professional relationships with external stakeholders, regulatory authorities and scientific and clinical advisors
• Prior experience and demonstrated ability to work in diverse therapeutic areas
• Strong leadership skills with ability to set a vision, lead change, grow a team and mentor others
• Experience leading regulatory authority communications and meetings

SCYNEXIS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

The starting pay for this role is between $235,000.00 and $275,000.00. The estimated salary range represents an anticipated range for this position. The actual base salary offered may vary based on a variety of factors.

We offer a competitive total rewards package that includes short-term and long-term incentive programs and a comprehensive benefits package, including medical, dental, and vision coverage, a 401(k) with company match, paid time off, and additional benefits.

SCYNEXIS, Inc. (NASDAQ: SCYX) is a publicly traded, clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases. Our pipeline includes two clinical-stage compounds: SCY-770, a novel, highly selective direct AMPK activator in development for autosomal dominant polycystic kidney disease (ADPKD), and SCY-247, a second-generation triterpenoid antifungal candidate currently in Phase 1 development for the treatment and prevention of invasive fungal infections.

We are seeking an experienced Director, Drug Product Development, to be based in our Jersey City, NJ office. This role will lead drug product strategy and execution across our clinical-stage portfolio, supporting the advancement of innovative therapies for patients with serious rare diseases.

The Director, Drug Product Development will lead formulation, manufacturing, and lifecycle activities for drug product candidates from development through clinical-stage execution. This role partners across CMC, Quality, Regulatory, Supply Chain, and external manufacturers to ensure drug products are robust, scalable, and aligned with program timelines and regulatory requirements.

• Drug Product Development Strategy: Lead drug product development strategy across the clinical-stage portfolio, including formulation design, process development, manufacturability, and lifecycle planning.
• Formulation & Clinical Supply Execution: Develop and optimize scalable dosage forms and manufacturing processes to support clinical studies, technical transfers, and reliable product supply. Conduct drug product risk assessment and develop risk mitigation plans.
• External Manufacturing Leadership: Select, oversee, and manage CDMOs, CMOs, and other external partners to ensure timely execution, quality performance, and alignment with program objectives.
• CMC Regulatory Support: Contribute to CMC strategy and author, review, or support regulatory submissions and responses, amendments, briefing documents, and other health authority interactions as needed.
• Cross-Functional Program Leadership: Partner closely with Analytical Development, Drug Substance, Quality, Regulatory, Clinical Operations, and Supply Chain to align technical plans with development timelines, budgets, and program priorities.
• Technical Representation & Governance: Represent drug product development in internal governance forums and external meetings with manufacturers, auditors, consultants, and development partners, serving as a key technical leader for product-related decisions.

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or related Physical Sciences with at least 12 years of experience, or M.S. with 15 years of experience working in drug product development in the pharmaceutical or biotechnology industry.
• In-depth knowledge and hands-on experience leading drug product development and CMC activities for small molecule programs in a clinical-stage biotechnology or pharmaceutical environment.
• Demonstrated success advancing programs through key development milestones, including clinical trial supply, process scale-up, technology transfer, and regulatory submissions.
• Strong working knowledge of CMC regulatory requirements and development expectations for IND-enabling and clinical-stage programs. Proven experience writing CMC drug product sections in regulatory submissions.
• Experience managing CDMOs, CMOs, and other external development and manufacturing partners, with the ability to drive accountability, timelines, and quality outcomes.
• Broad cross-functional CMC expertise, with the ability to work effectively across Drug Substance, Analytical, Quality, Regulatory, Supply Chain, and Clinical teams.
• Excellent written and verbal communication skills, including the ability to communicate complex technical issues clearly to internal and external stakeholders.
• Strong leadership, judgment, and problem-solving skills, with the ability to operate effectively in a fast-paced, resource-conscious, entrepreneurial environment.
• Proven ability to build productive relationships with external partners, consultants, and scientific advisors.
• Experience mentoring team members and contributing to a collaborative, high-accountability culture is preferred.

SCYNEXIS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

The starting pay for this role is between $200,000.00 and $235,000.00. The estimated salary range represents an anticipated range for this position. The actual base salary offered may vary based on a variety of factors.

We offer a competitive total rewards package that includes short-term and long-term incentive programs and a comprehensive benefits package, including medical, dental, and vision coverage, a 401(k) with company match, paid time off, and additional benefits.