Senior Regulatory Strategy Manager
VirtualVocationsLowell, Massachusetts, United Statesjob_description.job_card.variable_hours_ago
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A company is looking for a Sr Manager Global Regulatory Strategy to oversee clinical trial activities across multiple programs.
Key Responsibilities :
Serve as the regulatory affairs lead for clinical trial activities, including CTA submissions and agency interactions
Develop tailored regulatory strategies for assigned projects, incorporating clinical, nonclinical, and CMC considerations
Coordinate the preparation and submission of regulatory documents to relevant agencies, ensuring alignment with corporate objectives
Required Qualifications and Education :
Proven experience working within Global Regulatory Teams (GRTs) and cross-functional teams
Strong knowledge of drug development processes, ICH guidelines, and regulatory frameworks
Hands-on experience with INDs, CTAs, IMPDs, and Orphan Drug Designations
Clear understanding of submission content and format requirements
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Senior Manager Strategy • Lowell, Massachusetts, United States
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