Senior Regulatory Affairs Manager

1 week ago

Boston, MA, United States Katalyst Healthcares and Life Sciences Full time
  • The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle.
  • GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product.
  • It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence.
  • The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
  • The Regulatory Affairs Nonclinical / Clinical team plays a key role in defining the regulatory strategy and pathway for a product by leading the development and execution of the nonclinical / clinical regulatory strategy and plan in alignment the overall clinical development plan.
  • This team will take a lead role in planning and developing relevant sections of regulatory filings required for product approvals.
  • In addition, this team will lead planning, coordinating and engaging directly with Health Authorities before, during and after regulatory approval milestones.
Summary Description:
  • The Reg Nonclinical / Clinical Associate Director will lead, conceive, communicate and execute upon the global clinical and nonclinical regulatory strategies throughout a program's lifecycle that are in alignment with corporate goals and timelines.
  • This includes formulating the global Nonclinical / Clinical strategy for the Global Regulatory Plan, acting as the key liaison with Health Authorities and leading the preparation of Nonclinical / Clinical documentation to support global regulatory filings, including post-approval activities and life-cycle expansion opportunities.
  • The Company's Associate Director is viewed as a subject matter expert in the functional area involved in developing, modifying and executing on product strategies and have a function and may have a companywide impact.
  • The AD will typically collaborate, influence and negotiate with senior Nonclinical / Clinical leaders on product strategies and actions leveraging their advanced Nonclinical / Clinical knowledge.
Responsibilities:
  • Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle.
  • Ensure strategic alignment with the Clinical Development Plan (CDP) and nonclinical development plan with input from clinical and nonclinical Subject Matter Experts (SMEs), respectively, and regional regulatory leads.
  • Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate
  • In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the global nonclinical and clinical development strategy.
  • Incorporate RA INTL guidance on development programs (i.e., INTL requirements or policies that may impact clinical development and commercialization).
  • Develop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities.
  • Lead/support strategy for life-cycle expansion opportunities
  • Clinical and Nonclinical Development Plan Advancement
  • ct as a key contributor to the Clinical and Nonclinical Development Plans and ensure that they incorporate consideration of current global health authority precedents and regulatory guidance.
  • Provide both proactive and reactive strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studies
  • Contribute critically to the scientific interpretation and integration of clinical and nonclinical study results.
Education And Experience:
  • Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
  • 6 + year experience with PhD; 8+ years with Masters or bachelor's degrees
  • Nonclinical / Clinical Regulatory Affairs experience preferred

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