Protara Therapeutics

Protara Therapeutics

Director, Global Regulatory Affairs

New York, NY, Remote · Director

Sponsorship not specified$228k-$233kDetected 26 days ago
Project ManagementNegotiationClinical TrialsFDA RegulatoryCRISPRLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingPublic SpeakingOrganizational SkillsMicrosoft OfficeRegulatory Affairs

About the role

  • Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases.
  • 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.
  • Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source.

Responsibilities

  • 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.
  • Provide interpersonal support and lead personnel.

Requirements

  • 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.
  • 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.
  • Own the preparation of major clinical submissions required for regulatory approval.
  • Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals.
  • ability to coordinate and prioritize assigned projects according to company goals
  • The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • 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.
  • 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.

Nice to have

  • 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:

Skills

  • Must be proficient in MS Office Suite.
  • 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.
  • Strong analytical and problem-solving skills.
  • Proficiency in data mining/data extraction.
  • Demonstrated experience working with and presenting to senior level management.
  • Ability to work through uncertainty.
  • Certificates, Licenses, Registrations: none required
  • Other Skills and Abilities:

Compensation

  • Salary Requirements are between $228,000 - $233,000 based on job-related knowledge, experience, education, and skills demonstrated.

Benefits

  • 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.
  • Flexible working hours/schedule.
  • Generous Paid Holidays and Unlimited PTO.

Company info

  • 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.
  • Company-wide dedication to profoundly impacting patients' lives.

Visa & Work Authorization

  • ions experience and manage study specific regulatory submissions and will have country level experience either from the sponsor or CRO side managing global studies
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This listing is sourced directly from Protara Therapeutics's careers page and normalized into a canonical job model.