Director, Global Regulatory Affairs
Protara Therapeutics
6 hours ago
Remote friendly (New York, NY)
United States
Corporate Functions
Director, Global Regulatory Affairs (ex-US) — remotely or hybrid (NYC office)
Responsibilities
- Interpret regulatory authority feedback, policies, and guidelines.
- Lead study-level regulatory strategy; own preparation of major clinical submissions for regulatory approval.
- Resolve complex project issues with program/study teams; strategically interpret and communicate regulatory requirements to achieve approvals.
- Ensure quality and timeliness of IND/CTA submissions; prepare, review, and complete submission documents with internal partners.
- Plan, prioritize, supervise, and collaborate with cross-functional leads; assure compliance and adherence to timelines.
- Provide interpersonal support and lead personnel.
- Lead and/or supervise IND/CTA submissions (e.g., South America, APAC, EU, etc.); oversee CROs for ex-US CTAs/INDs toward trial activations (preferred).
Qualifications (Required)
- MD, Ph.D., or PharmD; excellent written/verbal communication.
- Minimum 10 years pharma industry experience; at least 7 years regulatory experience.
- 8–12+ years regulatory affairs in biopharma.
- Demonstrated success interacting with FDA, EMA, and other global authorities for oncology/cell & gene therapy/rare disease.
- Hands-on experience leading IND submissions and regulatory meetings.
- Strong understanding of CMC, nonclinical, and clinical requirements for advanced biologics.
Preferred
- BLA/MAA preparation/review support; familiarity with EMA/MHRA/PMDA/CDE.
- Rare disease natural history or patient-focused drug development.
- Biotech experience with first-in-human/first-in-class programs.
Skills/Tools
- Strong leadership, negotiation, and project management.
- Proficient MS Office (advanced Excel); NetSuite/Workday Adaptive/Smartsheet plus.
- Strong organizational detail; ability to handle confidential information; data mining/data extraction.
Benefits/Compensation (as stated)
- Salary $228,000–$233,000; incentive bonus, equity, matching 401(k), medical/dental/vision, commuter, fertility benefits.
Responsibilities
- Interpret regulatory authority feedback, policies, and guidelines.
- Lead study-level regulatory strategy; own preparation of major clinical submissions for regulatory approval.
- Resolve complex project issues with program/study teams; strategically interpret and communicate regulatory requirements to achieve approvals.
- Ensure quality and timeliness of IND/CTA submissions; prepare, review, and complete submission documents with internal partners.
- Plan, prioritize, supervise, and collaborate with cross-functional leads; assure compliance and adherence to timelines.
- Provide interpersonal support and lead personnel.
- Lead and/or supervise IND/CTA submissions (e.g., South America, APAC, EU, etc.); oversee CROs for ex-US CTAs/INDs toward trial activations (preferred).
Qualifications (Required)
- MD, Ph.D., or PharmD; excellent written/verbal communication.
- Minimum 10 years pharma industry experience; at least 7 years regulatory experience.
- 8–12+ years regulatory affairs in biopharma.
- Demonstrated success interacting with FDA, EMA, and other global authorities for oncology/cell & gene therapy/rare disease.
- Hands-on experience leading IND submissions and regulatory meetings.
- Strong understanding of CMC, nonclinical, and clinical requirements for advanced biologics.
Preferred
- BLA/MAA preparation/review support; familiarity with EMA/MHRA/PMDA/CDE.
- Rare disease natural history or patient-focused drug development.
- Biotech experience with first-in-human/first-in-class programs.
Skills/Tools
- Strong leadership, negotiation, and project management.
- Proficient MS Office (advanced Excel); NetSuite/Workday Adaptive/Smartsheet plus.
- Strong organizational detail; ability to handle confidential information; data mining/data extraction.
Benefits/Compensation (as stated)
- Salary $228,000–$233,000; incentive bonus, equity, matching 401(k), medical/dental/vision, commuter, fertility benefits.