Director, Global Regulatory Affairs

Company Overview:

Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara's portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source. This honor demonstrates the company's desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation. Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

Job Overview:

The Director, Global Regulatory Affairs leads Protara's ex-US regulatory strategy and operational execution for Protara's clinical studies in oncology, cell and gene therapy, and rare diseases. The leader will possess ex-US global submissions experience and manage study specific regulatory submissions and will have country level experience either from the sponsor or CRO side managing global studies. The Director, Global Regulatory Affairs will provide leadership on ex-US regulatory activities for Protara's product portfolio, and responsibility will focus on clinical study applications and provide regulatory leadership on the project teams in this area. The candidate will lead and/or supervise IND/CTA submissions including but not limited to South America, APAC, EU, etc.

*This person must be able to work remotely or hybrid in the NYC office.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Provide interpretation of regulatory authorities' feedback, policies, and guidelines.
• Lead the development of study level regulatory strategic plans either directly in conjunction with program and study teams. Own the preparation of major clinical submissions required for regulatory approval.
• Work with program and study teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals.
• Responsible for quality and timeliness of IND/CTA submissions. Interact with other functions and partners, in the preparation, review, and completion of documents for regulatory submissions.
• Successfully plan, prioritize, supervise and/or conduct activities in close collaboration with leads from other areas. Assure compliance with regulations and with program and study team timelines.
• Provide interpersonal support and lead personnel.
• Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams
• Strong understanding of global (US and ex-US) pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Oversight of CROs in the management of ex-US CTAs/INDs towards clinical trial activations preferred
• High attention to detail; ability to coordinate and prioritize assigned projects according to company goals
• You bring strong interpersonal skills both written and verbally.

Education/ Qualifications:

• To be considered, you must possess excellent written and verbal communication skills along with an MD, Ph.D., Pharm D. or master's degree. We expect a minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.
• 8-12+ years of regulatory affairs experience in the biopharmaceutical industry.
• Demonstrated success interacting with the FDA, EMA and other global health authorities for oncology, cell and gene therapy, or rare disease programs.
• Hands-on experience leading IND submissions and regulatory meetings.
• Strong understanding of CMC, nonclinical, and clinical requirements for advanced biologics.
• Excellent written and verbal communication skills, with the ability to translate complex science into clear regulatory positions.

Preferred Qualifications:

• Experience supporting BLA/MAA preparation or review.
• Familiarity with global regulatory frameworks (EMA, MHRA, PMDA, CDE).
• Background in rare disease natural history studies or patient focused drug development.
• Experience in a fast-paced biotech environment with first inhuman or first in class programs.

Computer Skills:

• Must be proficient in MS Office Suite.

Certificates, Licenses, Registrations: none required

Other Skills and Abilities:

• Strong interpersonal skills, including ability to communicate effectively with diverse audiences and build strong relationships
• Excellent written and oral communication and presentation skills.
• Ability to prioritize and multi-task successfully in a fast-paced environment.
• Excellent organizational skills and attention to detail are essential
• It is essential that this individual demonstrates the ability to work with highly confidential information.
• Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
• Strong analytical and problem-solving skills.
• Ability to work both independently and in a collaborative team setting.
• Proficiency in data mining/data extraction.
• Demonstrated experience working with and presenting to senior level management.
• Ability to work through uncertainty.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• No specific work demands.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

* Salary Requirements are between $228,000 - $233,000 based on job-related knowledge, experience, education, and skills demonstrated. We offer a competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.

Why You'll Love Working at Protara

• Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
• Company-wide dedication to profoundly impacting patients' lives.
• Amazing culture whereby our core values and behaviors are shared cross-functionally.
• Flexible working hours/schedule.
• Generous Paid Holidays and Unlimited PTO.

Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws.