Associate Director, Regulatory Operations

Company: Spero Therapeutics
Location: Cambridge
Posted on: April 9, 2021

Job Description:

Associate Director, Regulatory Operations Spero Therapeutics (Nasdaq: SPRO) is a multi-asset clinical stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotechnological and biopharmaceutical experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on the unmet needs of patients with multi-drug resistant (MDR) bacterial infections. Spero's lead product candidate, Tebipenem HBr, is an oral carbapenem currently being evaluated in a pivotal Phase 3 clinical trial for the treatment of complicated urinary tract infections. Spero is also advancing SPR720, its oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero's third product candidate, SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections. We sincerely believe that our novel product candidates will have meaningful impact on patient health and significant commercial applications for the treatment of MDR infections in both the hospital and community settings. NOTE: This position is currently remote and we will consider candidates who are within a reasonable travel distance to our Cambridge, MA headquarters--but who reside in other states, with the expectation that there will be periodic travel to MA. General Scope and Summary of Role Spero Therapeutics is looking for a collaborative, enthusiastic, experienced, hands-on partner responsible for leading the development and implementation of a robust Regulatory Operations function. This includes development of policies and processes for multiple products including the preparation of compliant submission-relevant documents relating to company's development activities for a growing company in the US and other countries.
-- What You'll Do:

• Lead the Regulatory Operations function within Regulatory Affairs
• Lead the implementation and training of Veeva RIM within the organization, working closely with IT. This includes development of associated processes and procedures.
• Be responsible for the implementation of and ongoing training to the organization on Regulatory Operations processes and systems including but not limited to changes to existing processes or systems, the introduction of new processes and/or systems such as submission publishing systems, and the training of new employees as necessary. In addition, be responsible for the oversight of user access management to Regulatory systems.
• Provide business ownership of the IT systems within the scope of Regulatory Operations, such as Veeva RIM, submission publishing, and others as necessary
• Build the Regulatory Operations infrastructure and define processes for the preparation of compliant regulatory submission to heath authorities
• Lead the Regulatory Operations department expansion from clinical focused into a commercial space
• Partner with IT on the change management, release management, and ongoing validation of all Regulatory Operation computer systems
• Work with Regulatory Leads, as well as other functional areas as needed, to schedule, manage and prepare submissions to support project plans and timelines for INDs, CTAs, NDAs, MAA and related submissions, as well as amendments and supplements to these applications and responses to regulatory agency requests.
• Coordinate collaboration with responsible departments and oversee preparation, review, and collection of documentation for regulatory submissions
• For electronic submissions, ensure documents are eCTD compliant
• Provide critical review of all documentation supporting regulatory applications
• Oversee the regulatory collaboration with external vendors and to meet regulatory requirements
• Oversee development of standard operating procedures and departmental guidelines with respect to Regulatory Affairs and Operations
• Maintain corporate Style Guide and document templates
• Train employees on Veeva RIM and preparation of submission documentation
• Oversee regulatory project timelines in keeping with corporate objectives. Actively participate on project teams advising on submission preparation timelines, processes, and requirements.
• Assume other relevant assignments as directed by the Head of Regulatory Affairs
• Provide Regulatory Operations expertise and guidance to the organization
  What You'll Need:
  • 10+ years of industry knowledge experience (pharma, biotech, CRO).
  • 8+ years of Regulatory Operations experience, NDA filing experience preferred.
  • Strong organizational skills, hands-on, direction-setting
  • Proficient in Microsoft Office applications and Adobe Acrobat. Preferred experience with StartingPoint templates and PleaseReview.
  • Expertise in Veeva RIM, system implementation experience a plus
  • Experience in a supervisory role
  • Strong understanding of Regulatory Operation comprehensive role and transformation from development to commercial as the company looks toward the future.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Strong team player that has a customer service approach and is solution oriented. In particular, experience with working with IT.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Knowledge of FDA post-approval regulations/commercial launch experience such as drug listing submission management is a plus.
  • Possesses strong written and verbal communication skills. By joining our committed and highly motivated team, you'll experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero's culture is one that emphasizes "servant leadership," or putting ego aside and working for the benefit of the team and our patients and values our colleagues' opinions and celebrates accomplishments in service of patients. The following questions are entirely optional. To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more . Invitation for Job Applicants to Self-Identify as a U.S. Veteran
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Keywords: Spero Therapeutics, Cambridge , Associate Director, Regulatory Operations, Executive , Cambridge, Massachusetts