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Senior Manager/Associate Director, Global Regulatory Affairs, Regulatory Project Management

Company: Athersys
Location: Cleveland
Posted on: January 16, 2022

Job Description:

AT ATHERSYS: Our people make the difference. We owe our success to the passionate, driven and growth-oriented people who have chosen to align their careers with our mission, "Committed to developing therapies to extend and enhance the quality of human life."

WE ARE SEEKING: A Senior Manager/Associate Director, Global Regulatory Affairs, Regulatory Project Management develops, disseminates, and provides continuous improvement for the business processes including, but not limited to: creating, tracking, and managing timelines, deliverables, resources, risks, and budgets; managing and overseeing regulatory document authoring; and participating in overall review for submissions to health authorities including and leading up to BLA/MAA/WMA supportive type documents.

Job Functions

  • Manage and coordinate the planning, timeline, budget, organization by priority activities related to ultimate submittal of regulatory packages for the FDA and other global regulatory agencies working closely with members of the Regulatory team and across Athersys and contracted CRO's, CMO's and consultant groups which involve the following:
    • Establish a comprehensive program management process within Regulatory
    • Maintain the system and continuing review processes and practices to assure optimal performance of the system
    • Participate in establishing the initial scope, goals, and deliverables of projects and assure these align with project sponsors, key stakeholders, and team members
    • Provide guidance to the project team in developing the tasks and resources required to deliver the project
    • Develop schedules and timelines for the project using tools such as Microsoft Project
    • Escalate issues and challenges associated with projects along with recommendations for options and alternatives
    • Develop systems and processes associated with management of external contract manufacturers and service providers
    • Manage regulatory projects and activities to ensure appropriate resourcing and prioritization to meet project submission timelines and document requirements, as needed
    • Communicates Regulatory Project Management's team position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.
    • Collaborate with multiple internal functional areas, external organizations/partners, and other key stakeholders to identify, communicate, and provide conflict resolution regarding any deviations from submission plans
    • Manage staff effectively to ensure milestones and service levels are met, including workload balance and day-to-day workflow, as requested
    • The individual in this role will work with cross-functional teams to create document review timelines and lead comment resolution through document review & editing.
    • Develops & maintains project timelines through collaboration with project teams, subject matter experts, and other cross functional partners to facilitate document clarity.
    • Overall review for content of documents prepared for submissions, including checking content of cross-referenced information for accurate support of statements made,
    • Overall review of nonclinical, clinical and CMC reports during the project management of the documents being authored and finalized.,
    • Overall review of nonclinical and clinical protocols as part of protocol reviews;
    • Overall review of clinical study reports during the project management of the documents being authored and finalized.
    • Help prepare sections of orphan drug applications, pediatric Development Plans, INDs, Scientific Advice packages, annual reports/DSURs, Investigator Brochures or other regulatory documents, as needed
    • Develop and manage internal Standard Operating Procedures relevant to Project Management activities and processes
    • Help prepare / review summary documents, meeting minutes and other documents for presentation, and for hand over to the Reg operations and Publication Team for submission to health authorities
    • Aligns with department management to set strategy for meeting department goals.
    • Identifies potential areas for process improvements and possible solutions and communicates these to line management or appropriate functional line.
    • Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner.
    • Produces documents in conjunction with vendors, as needed.
    • Experience with package inserts (labels) is a plus, including process management of creating a Package Insert is a plus
      Knowledge/Skills
      • Knowledge of project management principles and application
      • Comfortable working in a fast-paced work environment
      • Ability to work under pressure, adhere to deadlines and adapt to changing priorities
      • Strong work ethic and commitment to serve internal and external clients
      • Demonstrates strong leadership skills
      • Excellent judgment and decision-making skills
      • Excellent interpersonal skills and problem-solving ability
      • Effective organization and negotiation skills
      • Computer skills with proficiency in Microsoft Applications
      • In depth knowledge of FDA, EMA and international regulatory documents requirements , including global and industry trends for dossier module sections content requirements
      • Experience in helping with writing and editing; or previous experience authoring, editing, and reviewing regulatory documents is a good to have
      • Works collaboratively and interjects suggestions and opinions with internal and external peers, colleagues, and senior management
      • Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
      • Ability to manage documents of greater complexity and/or variety.
      • Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
      • Detail oriented; well organized; quick learner
      • Strong written, verbal, and interpersonal communication skills
      • Creative, out of the box thinker, can function autonomously with little supervision to establish a state-of-the-art regulatory operations functionality a major plus
      • Analytical thinking and inquisitive mindset for investigations and problem solving

        Education/Experience
        • Bachelor's degree in a scientific, pharmacy or related discipline. Master's or PhD degree in a related field a plus
        • Minimum of 3-10 years of related project management experience
        • Experience with MS Office, Teams, Adobe, Project Management Tools, and document management solutions
        • Medical writing experience (2+ years) a plus / advantage
        • Regulatory technical document review experience in clinical, nonclinical or CMC highly advantageous

          Athersys is an equal opportunity employer. Qualified applicants are considered for all positions without regard to age, race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other status protected by applicable law.

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Keywords: Athersys, Cleveland , Senior Manager/Associate Director, Global Regulatory Affairs, Regulatory Project Management, Executive , Cleveland, Ohio

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