Senior Manager, Regulatory Affairs

New York, NY

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.

Job Overview: 

 The Senior Manager, Regulatory Affairs, is responsible for supporting the implementation of the regulatory strategy and operations for investigational products for Protara’s clinical stage programs. This individual ensures compliance with 21 CFR Part 11; and supports regulatory US and ex-US regulatory submissions including supporting IND submissions and health authority engagement.

This position reports to Senior Director, Clinical Sciences & Regulatory Affairs.

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Support the development and implementation of regulatory strategies for assigned programs in alignment with program goals.
  • Lead or support the preparation, review and submission of regulatory documents (eg, IND, amendments, briefing documents, EU CTR submissions, other health authority documents).
  • Represents the Regulatory Affairs function at program team and study team meetings.
  • Collaborate with clinical, nonclinical, CMC, and PV teams to ensure compliance with global regulatory requirements.
  • Supports planning, review and preparation for health authority interactions including FDA and EMA, including study specific regulatory submissions.
  • Manage timelines and ensure quality in all regulatory submissions.
  • Manages preparation, review and filing of documents to health authorities including INDs, BLAs, NDAs, etc.
  • Development (planning, reviewing, authoring) of nonclinical and clinical regulatory documents for FDA submission.
  • Manages and supports development of company responses to information requests from health authorities.
  • Monitor and interpret US and global regulations, regulatory guidelines and publications to keep apprised of new regulatory developments, and to ensure best practices and proactive compliance.
  • Develop best practices and ongoing improvement for regulatory document development and   submissions processes.

Education and/or Experience: 

  • Bachelor’s degree or equivalent in Pharmacy, Life Sciences or related scientific discipline required.
  • Minimum 5+ years of Regulatory Affairs experience in a biotech/pharmaceutical industry.
  • Must have experience in filing IND, NDAs in CTD/eCTD formats.
  • Demonstrated experience in successfully filing IND’s NDA’s, MAA’s, and/or BLA’s to Health Authorities.
  • Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices.

Supervisory Responsibilities:

  • None.

Qualifications: 

  • Strong knowledge of global regulatory affairs requirements with a strong focus on US EU and ICH requirements.
  • Prior experience with DocCompliance and MedXview or other web-based document management/publishing software for electronic submissions is preferred.

Computer Skills:

  • Must be proficient in MS Office Suite and Adobe Acrobat.

Other Skills and Abilities:

  • Excellent writing, communication, and presentation skills.
  • Ability to contribute to multiple projects from an operations perspective.
  • Strong negotiation and collaboration skills.
  • Ability to identify compliance risks and resolve or escalate when necessary.
  • Experience in addressing complex problems or processes.
  • Demonstrated ability to work within a cross functional team and a matrix environment.
  • Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
  • Strong skills in planning, organizing, decision-making and problem-solving.
  • Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.
  • Strong ability to prioritize tasks, with a keen attention to detail.
  • Demonstrated ability to stay abreast of trends and new information in the profession.

 *Salary Requirements are between $150,000 - $160,000 based on experience and qualifications.

 Physical Demands:

  • This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives.
  • Able to work in a fast-paced demanding environment to meet the regulatory needs for the company.

 Work Environment:

  • No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 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 we live by our core values and behaviors
  • Competitive Salary and Benefits package to include incentive bonus, equity compensation, medical, dental, vision, and life insurance
  • Matching 401(k) Retirement Plan
  • Flexible working hours/schedule
  • Generous Paid Holidays, Unlimited PTO, and Parental Leave

 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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