Protara Therapeutics
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Senior Manager, Regulatory Affairs
role at
Protara Therapeutics
2 days ago Be among the first 25 applicants
Company Overview Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Its portfolio includes the lead candidate TARA-002, an investigational cell-based therapy for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The company is conducting Phase 2 trials for these conditions and developing IV Choline Chloride for patients on parenteral support.
Job Overview The Senior Manager, Regulatory Affairs, supports regulatory strategy and operations for clinical stage programs, ensuring compliance with 21 CFR Part 11, and assisting with US and ex-US regulatory submissions, including IND submissions and health authority engagement. Reports to the Senior Director, Clinical Sciences & Regulatory Affairs.
Responsibilities
Develop and implement regulatory strategies aligned with program goals.
Lead or support preparation, review, and submission of regulatory documents (IND, amendments, briefing documents, EU CTR submissions, etc.).
Represent Regulatory Affairs in program and study team meetings.
Collaborate with clinical, nonclinical, CMC, and PV teams to ensure compliance with global regulations.
Plan and prepare for health authority interactions, including FDA and EMA submissions.
Manage timelines and quality for regulatory submissions.
Prepare and review documents for health authorities like INDs, BLAs, NDAs.
Develop nonclinical and clinical regulatory documents for FDA submissions.
Support responses to information requests from health authorities.
Monitor and interpret US and global regulations to ensure compliance and incorporate best practices.
Improve regulatory document development and submission processes.
Qualifications
Bachelor’s degree in Pharmacy, Life Sciences, or related field.
At least 5+ years in Regulatory Affairs within biotech/pharmaceutical industry.
Experience filing INDs and NDAs in CTD/eCTD formats.
Successful track record with IND, NDA, MAA, ANDA, BLA submissions.
Knowledge of US FDA and international pharmaceutical regulations and drug development processes.
Additional Skills
Strong knowledge of US, EU, and ICH regulatory requirements.
Experience with document management software like DocCompliance and MedXview is preferred.
Proficiency in MS Office and Adobe Acrobat.
Excellent communication, negotiation, and collaboration skills.
Ability to manage multiple projects in a fast-paced environment.
Strong organizational and problem-solving skills.
Effective at working within cross-functional teams.
Other Details
Salary: $150,000 - $160,000, based on experience.
Minimal travel required (5-10%).
Work environment is adaptable; accommodations available for disabilities.
Why Join Us
Inclusive, diverse, and collaborative culture.
Impactful work improving patient lives.
Competitive salary, benefits, and flexible work schedule.
Generous PTO, holidays, parental leave, and 401(k) matching.
Protara is an Equal Opportunity Employer committed to diversity and inclusion.
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Senior Manager, Regulatory Affairs
role at
Protara Therapeutics
2 days ago Be among the first 25 applicants
Company Overview Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Its portfolio includes the lead candidate TARA-002, an investigational cell-based therapy for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The company is conducting Phase 2 trials for these conditions and developing IV Choline Chloride for patients on parenteral support.
Job Overview The Senior Manager, Regulatory Affairs, supports regulatory strategy and operations for clinical stage programs, ensuring compliance with 21 CFR Part 11, and assisting with US and ex-US regulatory submissions, including IND submissions and health authority engagement. Reports to the Senior Director, Clinical Sciences & Regulatory Affairs.
Responsibilities
Develop and implement regulatory strategies aligned with program goals.
Lead or support preparation, review, and submission of regulatory documents (IND, amendments, briefing documents, EU CTR submissions, etc.).
Represent Regulatory Affairs in program and study team meetings.
Collaborate with clinical, nonclinical, CMC, and PV teams to ensure compliance with global regulations.
Plan and prepare for health authority interactions, including FDA and EMA submissions.
Manage timelines and quality for regulatory submissions.
Prepare and review documents for health authorities like INDs, BLAs, NDAs.
Develop nonclinical and clinical regulatory documents for FDA submissions.
Support responses to information requests from health authorities.
Monitor and interpret US and global regulations to ensure compliance and incorporate best practices.
Improve regulatory document development and submission processes.
Qualifications
Bachelor’s degree in Pharmacy, Life Sciences, or related field.
At least 5+ years in Regulatory Affairs within biotech/pharmaceutical industry.
Experience filing INDs and NDAs in CTD/eCTD formats.
Successful track record with IND, NDA, MAA, ANDA, BLA submissions.
Knowledge of US FDA and international pharmaceutical regulations and drug development processes.
Additional Skills
Strong knowledge of US, EU, and ICH regulatory requirements.
Experience with document management software like DocCompliance and MedXview is preferred.
Proficiency in MS Office and Adobe Acrobat.
Excellent communication, negotiation, and collaboration skills.
Ability to manage multiple projects in a fast-paced environment.
Strong organizational and problem-solving skills.
Effective at working within cross-functional teams.
Other Details
Salary: $150,000 - $160,000, based on experience.
Minimal travel required (5-10%).
Work environment is adaptable; accommodations available for disabilities.
Why Join Us
Inclusive, diverse, and collaborative culture.
Impactful work improving patient lives.
Competitive salary, benefits, and flexible work schedule.
Generous PTO, holidays, parental leave, and 401(k) matching.
Protara is an Equal Opportunity Employer committed to diversity and inclusion.
#J-18808-Ljbffr