Katalyst CRO ยท 1 month ago
Senior Regulatory Affairs Manager
Boston, MA
Contract
Onsite
Senior Level, Lead/Staff, Director/Executive
6+ years expKatalyst CRO is a company focused on regulatory affairs and clinical development. The Senior Regulatory Affairs Manager will lead the global clinical and nonclinical regulatory strategies throughout a program's lifecycle and act as a key liaison with Health Authorities, ensuring compliance and strategic alignment with corporate goals.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
Preferred
Nonclinical / Clinical Regulatory Affairs experience preferred
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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