BioTalent
Senior Manager, Regulatory Operations (Contractor)
BioTalent, San Diego, California, United States, 92189
Overview
Senior Manager, Regulatory Operations (Contractor) This role supports the oversight of global regulatory submission processes, electronic publishing, and regulatory systems management, with a focus on Regulatory Information Management (RIM) systems. The position drives regulatory submission excellence, process optimization, and system innovation, ensuring timely execution of regulatory filings across multiple global health authorities. The role includes subject matter expertise in RIM platforms, with accountability for Common Technical Document (eCTD) submissions, global regulatory compliance, and document management best practices. Responsibilities
Oversee and manage Regulatory Information Management (RIM) systems Manage regulatory publishing systems and processes Lead planning, publishing, and execution of global regulatory submissions including INDs, CTAs, and future NDA/MAA filings Support infrastructure for eCTD publishing, document templates, and RIM systems Manage timelines and resources for all regulatory submissions, ensuring alignment with program goals and regulatory strategy Contribute to continuous improvement of regulatory systems and processes (RIM, Publishing, etc.) Maintain submission archives in compliance with global standards Qualifications
Bachelors degree in life sciences or related field 7+ years of experience in Regulatory Operations within the biotech or pharmaceutical industry, supporting clinical-stage programs Strong expertise with eCTD publishing and global submission management (IND, CTA, BLA/NDA, MAA) Solid knowledge of FDA, EMA, ICH, and other global regulatory requirements Proficiency with regulatory systems (e.g., Veeva Vault RIM, Lorenz, or equivalent) Demonstrated ability to manage projects in a fast-paced, dynamic environment Excellent collaboration, organizational, and communication skills Contract & Employment Details
Contract Term:
12 months Seniority level:
Mid-Senior level Employment type:
Contract Job Function & Industries
Job function: Project Management, Management, and Science Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
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Senior Manager, Regulatory Operations (Contractor) This role supports the oversight of global regulatory submission processes, electronic publishing, and regulatory systems management, with a focus on Regulatory Information Management (RIM) systems. The position drives regulatory submission excellence, process optimization, and system innovation, ensuring timely execution of regulatory filings across multiple global health authorities. The role includes subject matter expertise in RIM platforms, with accountability for Common Technical Document (eCTD) submissions, global regulatory compliance, and document management best practices. Responsibilities
Oversee and manage Regulatory Information Management (RIM) systems Manage regulatory publishing systems and processes Lead planning, publishing, and execution of global regulatory submissions including INDs, CTAs, and future NDA/MAA filings Support infrastructure for eCTD publishing, document templates, and RIM systems Manage timelines and resources for all regulatory submissions, ensuring alignment with program goals and regulatory strategy Contribute to continuous improvement of regulatory systems and processes (RIM, Publishing, etc.) Maintain submission archives in compliance with global standards Qualifications
Bachelors degree in life sciences or related field 7+ years of experience in Regulatory Operations within the biotech or pharmaceutical industry, supporting clinical-stage programs Strong expertise with eCTD publishing and global submission management (IND, CTA, BLA/NDA, MAA) Solid knowledge of FDA, EMA, ICH, and other global regulatory requirements Proficiency with regulatory systems (e.g., Veeva Vault RIM, Lorenz, or equivalent) Demonstrated ability to manage projects in a fast-paced, dynamic environment Excellent collaboration, organizational, and communication skills Contract & Employment Details
Contract Term:
12 months Seniority level:
Mid-Senior level Employment type:
Contract Job Function & Industries
Job function: Project Management, Management, and Science Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
#J-18808-Ljbffr