Strategic Regulatory Program Lead

5 days ago

Brisbane, Queensland, Australia beBeeProgram Full time $180,000 - $300,000
Regulatory Program Manager Job

The ideal candidate will oversee the planning and execution of a lead late-stage development program, ensuring regulatory alignment with organizational objectives.

  • Develop comprehensive regulatory plans, timelines, and budgets for our program while ensuring Regulatory alignment with organizational objectives.
  • Act as liaison between Regulatory and other Development functions; gathering and disseminating key decisions and updates across cross-functional workstreams and activities.
  • Provide Regulatory Submission Program Management support including timeline development, issue and risk management, status reporting and meeting facilitation both generally and for specific modules.
  • Work with other program managers to integrate module timelines and deliverables into the overall Regulatory Submission plans.
  • Collaborate with Regulatory and cross functional stakeholders to manage timeline for submission documents, including IB, DSUR, PSUR, ODD annual updates, and annual reports.
  • Support development and maintenance of the Smartsheet environment necessary to manage Regulatory filings, including creating/maintaining templates and dashboards, setting up automation and transferring existing plans.
  • Provide program management support for briefing documents and agency meetings.
  • Coordinate submission scheduling with regulatory publishing and ensure delivery of high-quality documents.

Requirements:

  • Bachelor's degree in life sciences or related field with 8+ years of experience in biotechnology industry required.
  • Strong knowledge of biopharmaceutical industry regulations and global filings required.
  • High level of accuracy and attention to detail.
  • Ability to work with ambiguity, and create new processes; desire to bring order and organization to a team.
  • Ability to communicate effectively with stakeholders at all levels.
  • Proven ability to manage competing priorities, timelines, and budgets in a fast-paced environment.
  • Skilled at working collaboratively with cross-functional teams to drive results and meet company objectives.
  • Ability to distill, organize, and communicate key messages from complex discussions.
  • Self-directed and proactive with ability to function independently, exercise good judgment, and respond quickly to changing environments.
  • Ability to deal with uncertainty and unanticipated challenges in a constructive manner.
  • Demonstrated people management skills, specifically managing program managers.
  • Experience in Smartsheet is a plus.
  • Proficient in Microsoft Office tools.

Vera Therapeutics Inc. is an equal-opportunity employer. This job description reflects the duties performed by the person occupying this position, but may not include all of the tasks that the employee may be required to perform. Vera Therapeutics Inc. reserves the right to revise or change job duties as needed. All offers are contingent on the candidate providing a background check clearance before their first day of work.

  • Strategic Regulatory Lead

    6 days ago

    Brisbane, Queensland, Australia beBeeRegulatory Full time $180,000 - $230,000

    Job DescriptionThe Head of Regulatory Affairs is a key role within our organization, responsible for developing and maintaining an effective regulatory engagement strategy.This includes promoting understanding of the regulatory environment, emerging themes, and areas of regulator focus across the enterprise.The successful candidate will maintain strong...

  • Regulatory Compliance Lead

    2 days ago

    Brisbane, Queensland, Australia beBeeStrategic Full time $120,290 - $129,379

    Job DescriptionThe role of an Assistant Director involves providing strategic leadership to support the achievement of regulatory outcomes in line with the department's business plan and strategic direction. The successful candidate will need to influence change, while contributing to business planning and decision-making processes.Duties may include leading...

  • Senior Regulatory Lead

    1 day ago

    Brisbane, Queensland, Australia beBeeRegulatory Full time $129,089 - $138,273

    About the RoleThis position involves leading a team responsible for assessing police and adverse information to determine who is eligible to hold a Blue Card.Provide strategic direction to the Eligibility Assessment Team.Assess complex cases and ensure decisions align with legislative requirements.This role requires making high-impact, evidence-based...

  • Strategic Program Lead

    6 days ago

    Brisbane, Queensland, Australia beBeeChild Full time $109,350 - $143,600

    Job Title: Strategic Program LeadOverview: We are seeking a highly experienced and skilled professional to lead the development, implementation, and project management of departmental and whole-of-government programs and strategies in relation to human services for children and families across Queensland.Responsibilities:Provide leadership to the work unit,...

  • Strategic Regulatory Advisor

    2 weeks ago

    Brisbane, Queensland, Australia beBeeRegulatory Full time $110,416 - $129,956

    Job OpportunityThis is a challenging and rewarding role that offers the opportunity to make a real difference in shaping regulatory strategy and providing critical operational support within a department.We are seeking an individual who can contribute to initiatives that directly influence the department's regulatory functions and outcomes for...

  • Principal Regulatory Compliance Lead

    4 days ago

    Brisbane, Queensland, Australia beBeeRegulatory Full time $140,000 - $185,999

    Our Principal Regulatory Compliance Officer role is a challenging opportunity to contribute to maintaining and upholding regulatory standards across the industry.We are seeking an experienced professional to lead our team in delivering high-quality regulatory services. Key responsibilities include:Managing a team of professionals to ensure effective delivery...

  • Regulatory Lead

    5 days ago

    Brisbane, Queensland, Australia beBeeRegulatory Full time $106,400 - $128,880

    Job Summary:The position of Regulatory Lead is a key role within the organization. The successful candidate will be responsible for developing and maintaining collaborative working relationships with internal and external stakeholders to achieve regulatory outcomes.Key Responsibilities:Developing and leading assessment and rating squads, including providing...

  • Employment Opportunities

    5 days ago

    Brisbane, Queensland, Australia beBeeStrategy Full time $90,000 - $120,000

    Alternate Workers' Compensation Programs SpecialistThis role involves supporting clients in exploring large employer premium arrangements within the Australian workers' compensation market. The position requires leading feasibility assessments and strategic planning for client workers' compensation programs.Key Responsibilities:Lead feasibility assessments...

  • Strategic Compliance Lead

    5 days ago

    Brisbane, Queensland, Australia beBeeCompliance Full time $95,000 - $135,000

    Job Description:">As a senior compliance professional, you will lead the strategic approach and support services to deliver the department's regulatory role. This includes leading a team responsible for the Water Resource Management Regulatory Strategy, preparation and oversight of the Annual Compliance Plan and associated reporting, development of...

  • Strategic Regulatory Content Manager

    2 weeks ago

    Brisbane, Queensland, Australia beBeeCompliance Full time $80,000 - $120,000

    **Regulatory Compliance Specialist Job Overview:**We are seeking a skilled and strategic professional to join our dynamic Regulatory Compliance team. The successful candidate will play a pivotal role in shaping how regulatory content is developed, positioned, and delivered to customers across various sectors.**Key Responsibilities:**Manage the lifecycle of...