Executive Director, Regulatory Affairs, Global

International / ex-US Regulatory Affairs Focus:

This position is specifically focused on international regulatory affairs supporting development and approvals in regions outside of the United States. Applicants should have experience filing marketing applications outside of the US. Experience supporting clinical trial applications in regions such as China and Japan is a strong plus.

Position Summary:

Reporting to the VP, Regulatory Affairs, the Global Executive Director of Regulatory Affairs will lead and participate in global regulatory activities developing innovative global regulatory strategies and providing strategic regulatory guidance for global development.  The Executive Director, Regulatory Affairs, Global, supports regulatory strategy and regulatory submissions, ensuring compliance with global regulatory requirements. This role will involve day-to-day tasks such as overseeing regulatory activities, coordinating with internal and external stakeholders, mentoring junior staff, and staying updated on relevant regulations and industry trends. This role requires an independent, self-directed, and highly motivated clinical regulatory professional. This role also includes mentoring and supervising direct reports.

Responsibilities:

• Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives
• Provide regulatory leadership and participate in regulatory activities associated with ex-US marketing applications and CTA development and maintenance for support of new and ongoing clinical trials.
• Represent regulatory on marketing application submission teams as well as clinical study and clinical development program teams throughout study conduct and product development.
• Plan, author, and execute and/or review regulatory documents required for product development (e.g. New IND/CTAs, DSUR, Meeting Requests/Briefing Packages, iPSP/PIP, NDA/MAA).
• Lead development of global regulatory submissions, including responses to health authority requests for information, as required.\
• Provide oversight of regulatory submissions to assure technical accuracy, compliance, and completeness.
• Provide regulatory support for company compliance initiatives, including SOP development, Veeva and documentation initiatives.
• Review relevant clinical documents (protocol, informed consent form, investigator’s brochure, and site documentation, and required regulatory forms) for regulatory compliance.
• Keep current on US and OUS regulations that apply to company products and processes.
• In-depth understanding of regulations and guidelines governing all phases (pre-IND through post-approval) of drug development and working knowledge of US regulations and practices pertaining to the development, manufacture, testing and distribution of pharmaceutical products.
• Monitors compliance with regulatory requirements and commitments.
• Develops, mentors, and manages work assignments of direct reports.
• Other duties as assigned.

Qualifications:

Required:

• BS/ MS/ PhD in a relevant scientific discipline with a minimum of 15 years in the biopharmaceutical industry 10+ years of experience in pharmaceutical or biotech regulatory affairs including clinical regulatory affairs for oncology products.
• Independent, self-directed, and highly motivated clinical regulatory professional.
• Ability to translate regulatory requirements into practical workable plans
• Experience working in small and mid-sized biopharmaceutical companies is highly desirable.
• Diverse experience with regulatory activities including creation of systems and processes to support efficient and high-quality submission of documents to regulatory bodies.
• Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail.
• Ability to build strong relationships with co-workers of various backgrounds and expertise.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.

Preferred:

• Advanced scientific degree with 15+ yrs experience in regulatory affairs

About Us:

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.

Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $265,000-$300,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

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