Director, Global Regulatory Affairs
BioSpace, New York, NY, United States
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.
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, focusing on clinical study applications and providing 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 role may be remote or hybrid in the NYC office.
Essential Duties and Responsibilities
Provide interpretation of regulatory authorities’ feedback, policies, and guidelines.
Lead the development of study‑level regulatory strategic plans in conjunction with program and study teams, and own the preparation of major clinical submissions required for regulatory approval.
Work with program and study teams to resolve complex project issues, strategically interpreting regulatory requirements to ensure attainment of governmental approvals.
Ensure quality and timeliness of IND/CTA submissions, interacting with other functions and partners during the preparation, review, and completion of documents for regulatory submissions.
Plan, prioritize, supervise, and/or conduct activities in close collaboration with leads from other areas, assuring compliance with regulations and with program and study team timelines.
Provide interpersonal support and lead personnel.
Demonstrate critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills, as evidenced by past performance on drug development project teams.
Maintain a strong understanding of global (US and ex‑US) pharmaceutical guidance, regulations, drug development processes, and industry standard practices.
Oversee CROs in the management of ex‑US CTAs/INDs toward clinical trial activations (preferred).
Pay high attention to detail and coordinate and prioritize assigned projects according to company goals.
Bring strong interpersonal skills, both written and verbal.
Education and Qualifications
Excellent written and verbal communication skills, MD, Ph.D., or Pharm D degree.
Minimum of 10 years of pharmaceutical industry experience, at least 7 years with 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.
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‑in‑human or first‑in‑class programs.
Computer Skills
Proficient in MS Office Suite, with advanced skills in Excel.
Experience with NetSuite, Workday Adaptive and/or Smartsheet is a plus.
Certificates, Licenses, Registrations None required.
Other Skills and Abilities
Strong interpersonal skills, ability to communicate with diverse audiences and build 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.
Ability to work with highly confidential information.
Ability to manage both day‑to‑day operations and 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
Minimal travel; average travel for this position is 5–10%.
Work Environment
No specific work demands.
Salary and Benefits Salary requirements are between $228,000 and $233,000 based on job‑related knowledge, experience, education, and skills demonstrated. The company offers a competitive compensation and 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 where 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.
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Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source.
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, focusing on clinical study applications and providing 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 role may be remote or hybrid in the NYC office.
Essential Duties and Responsibilities
Provide interpretation of regulatory authorities’ feedback, policies, and guidelines.
Lead the development of study‑level regulatory strategic plans in conjunction with program and study teams, and own the preparation of major clinical submissions required for regulatory approval.
Work with program and study teams to resolve complex project issues, strategically interpreting regulatory requirements to ensure attainment of governmental approvals.
Ensure quality and timeliness of IND/CTA submissions, interacting with other functions and partners during the preparation, review, and completion of documents for regulatory submissions.
Plan, prioritize, supervise, and/or conduct activities in close collaboration with leads from other areas, assuring compliance with regulations and with program and study team timelines.
Provide interpersonal support and lead personnel.
Demonstrate critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills, as evidenced by past performance on drug development project teams.
Maintain a strong understanding of global (US and ex‑US) pharmaceutical guidance, regulations, drug development processes, and industry standard practices.
Oversee CROs in the management of ex‑US CTAs/INDs toward clinical trial activations (preferred).
Pay high attention to detail and coordinate and prioritize assigned projects according to company goals.
Bring strong interpersonal skills, both written and verbal.
Education and Qualifications
Excellent written and verbal communication skills, MD, Ph.D., or Pharm D degree.
Minimum of 10 years of pharmaceutical industry experience, at least 7 years with 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.
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‑in‑human or first‑in‑class programs.
Computer Skills
Proficient in MS Office Suite, with advanced skills in Excel.
Experience with NetSuite, Workday Adaptive and/or Smartsheet is a plus.
Certificates, Licenses, Registrations None required.
Other Skills and Abilities
Strong interpersonal skills, ability to communicate with diverse audiences and build 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.
Ability to work with highly confidential information.
Ability to manage both day‑to‑day operations and 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
Minimal travel; average travel for this position is 5–10%.
Work Environment
No specific work demands.
Salary and Benefits Salary requirements are between $228,000 and $233,000 based on job‑related knowledge, experience, education, and skills demonstrated. The company offers a competitive compensation and 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 where 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.
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