Director, Global Regulatory Affairs

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 Bio Space, 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.

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.

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.

• To be considered, you must possess excellent written and verbal communication skills along with an MD, Ph.D., or Pharm
  
  D. degree. We expect a minimum of 10 years of pharmaceutical industry experience, at least 7 of…