Senior Regulatory Affairs Manager (Boston)

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Location: Cambridge, MA

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.
• Act 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 & 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.

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Legal

Industries

Pharmaceutical Manufacturing

Cambridge, MA $193,000.00-$210,000.00 1 month ago