Senior Manager/Associate Director, Regulatory Operations
Scorpion Therapeutics, Malverne Park Oaks, New York, United States
Role Summary
The Senior Manager / Associate Director of Regulatory Operations will lead the planning, preparation, and execution of regulatory submissions to advance Ocugen’s biologics, cell, and gene therapy programs. This role provides strategic and operational leadership for global regulatory submission activities, ensuring compliance with electronic submission standards, and driving cross-functional alignment to meet critical regulatory milestones.
Responsibilities
Lead and oversee the preparation, formatting, publishing, and submission of regulatory documents for INDs, IMPDs, BLAs, MAAs, and amendments.
Ensure submissions are fully compliant with FDA, EMA, Health Canada, and ICH electronic submission standards (eCTD).
Provide oversight of regulatory publishing activities, including vendor management and internal coordination, to achieve on-time delivery.
Establish and maintain submission trackers, dashboards, and metrics for organizational visibility and audit readiness.
Provide high-level review of submission components (CMC, clinical, safety) for accuracy, consistency, and compliance.
Drive best practices in document lifecycle management, including version control, archival, and audit preparedness.
Serve as a subject matter expert, monitoring changes in regulatory requirements and proactively updating processes and systems.
Partner with Regulatory Affairs, Clinical, CMC, Quality, and Medical Writing leadership to align submission strategies with development goals.
Advise internal stakeholders on regulatory submission requirements, timelines, and risks.
Lead collaboration with IT and external vendors to optimize submission platforms and tools, driving efficiency and compliance.
Provide mentorship and guidance to junior Regulatory Operations staff.
Manage vendor relationships to ensure quality and timeliness of outsourced publishing activities.
Contribute to department planning, resource allocation, and process improvement initiatives.
Qualifications
Bachelor’s degree in life sciences or related field required; advanced degree preferred.
7–10 years of experience in Regulatory Operations within the biotechnology or pharmaceutical industry, with increasing leadership responsibility.
Proven expertise in global regulatory submission requirements, including FDA, EMA, Health Canada, and ICH guidelines.
Demonstrated proficiency in eCTD publishing, electronic submission platforms, and regulatory information management systems (RIMS).
Experience managing teams and/or vendors to deliver complex submissions on accelerated timelines.
Strong organizational skills with the ability to prioritize and lead multiple projects simultaneously.
Exceptional communication and influencing skills; able to effectively partner with cross-functional leaders and external stakeholders.
Additional Requirements
Working Conditions: This position operates in an office setting, in person. May require availability outside of standard hours to handle priority business needs.
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Responsibilities
Lead and oversee the preparation, formatting, publishing, and submission of regulatory documents for INDs, IMPDs, BLAs, MAAs, and amendments.
Ensure submissions are fully compliant with FDA, EMA, Health Canada, and ICH electronic submission standards (eCTD).
Provide oversight of regulatory publishing activities, including vendor management and internal coordination, to achieve on-time delivery.
Establish and maintain submission trackers, dashboards, and metrics for organizational visibility and audit readiness.
Provide high-level review of submission components (CMC, clinical, safety) for accuracy, consistency, and compliance.
Drive best practices in document lifecycle management, including version control, archival, and audit preparedness.
Serve as a subject matter expert, monitoring changes in regulatory requirements and proactively updating processes and systems.
Partner with Regulatory Affairs, Clinical, CMC, Quality, and Medical Writing leadership to align submission strategies with development goals.
Advise internal stakeholders on regulatory submission requirements, timelines, and risks.
Lead collaboration with IT and external vendors to optimize submission platforms and tools, driving efficiency and compliance.
Provide mentorship and guidance to junior Regulatory Operations staff.
Manage vendor relationships to ensure quality and timeliness of outsourced publishing activities.
Contribute to department planning, resource allocation, and process improvement initiatives.
Qualifications
Bachelor’s degree in life sciences or related field required; advanced degree preferred.
7–10 years of experience in Regulatory Operations within the biotechnology or pharmaceutical industry, with increasing leadership responsibility.
Proven expertise in global regulatory submission requirements, including FDA, EMA, Health Canada, and ICH guidelines.
Demonstrated proficiency in eCTD publishing, electronic submission platforms, and regulatory information management systems (RIMS).
Experience managing teams and/or vendors to deliver complex submissions on accelerated timelines.
Strong organizational skills with the ability to prioritize and lead multiple projects simultaneously.
Exceptional communication and influencing skills; able to effectively partner with cross-functional leaders and external stakeholders.
Additional Requirements
Working Conditions: This position operates in an office setting, in person. May require availability outside of standard hours to handle priority business needs.
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