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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
      • A "disabled veteran" is one of the following:
        • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
        • a person who was discharged or released from active duty because of a service-connected disability.
        • A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
        • An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
        • An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE
          I AM NOT A PROTECTED VETERAN
          I DON'T WISH TO ANSWER Voluntary Self-Identification of Disability Voluntary Self-Identification of Disability Form CC-305
          OMB Control Number 1250-0005
          Expires 5/31/2023 Why are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
          • Autism
          • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
          • Blind or low vision
          • Cancer
          • Cardiovascular or heart disease
          • Celiac disease
          • Cerebral palsy
          • Deaf or hard of hearing
          • Depression or anxiety
          • Diabetes
          • Epilepsy
          • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
          • Missing limbs or partially missing limbs
          • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
          • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Please check one of the boxes below: YES, I HAVE A DISABILITY, OR HAVE A HISTORY/RECORD OF HAVING A DISABILITY NO, I DON'T HAVE A DISABILITY, OR A HISTORY/RECORD OF HAVING A DISABILITY I DON'T WISH TO ANSWER PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Spero Therapeutics, Cambridge , Associate Director, Regulatory Operations, Executive , Cambridge, Massachusetts

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