Associate Director, Regulatory Affairs Operations
3 days ago
The Associate Director, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases.You’ll work closely with Regulatory Affairs and cross-functional partners to manage timelines, ensure submission readiness, and strengthen operational excellence across the organization.Key Responsibilities: Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables.This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities.Serve as submission manager and primary contact for publishing vendors and internal stakeholders.Oversee regulatory document management, tracking, and archival activities.Manage regulatory systems (., Veeva RIM, PromoMats), and serve as internal subject matter expert (SME) for training and support to internal stakeholdersDevelop and implement processes, templates, and tools that improve submission efficiency and consistency.Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases. Provide subject matter expertise on regulatory technologies and submission best practices.Monitor new regulations and industry trends to assess impact on operational practices.Basic Qualifications: Bachelor’s degree in a scientific or related field.At least 10 years of related experience, with at least 8 years of regulatory operations experience in the biotech or pharmaceutical industry.Preferred Qualifications: Strong understanding of eCTD submission standards and regulatory requirements across global regions.Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management.Experience managing outsourced publishing vendors a plus.Skilled at balancing strategic oversight with hands-on execution.Strong communicator and collaborator with excellent organizational skills.
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Waltham, MA, United States Alkermes Full timeJob Description The Associate Director, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases....
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Waltham, MA, United States Alkermes Full timeJob Description The Associate Director, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases....
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Waltham, MA, United States Alkermes Full timeJob Description The Associate Director, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases....
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Waltham, MA, United States Alkermes Full timeJob Description The Associate Director, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases....
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Associate Director, CMC Regulatory Affairs
2 weeks ago
Waltham, United States Alkermes Full timeRegulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. Our team is driven by strategic excellence, collaborative spirit, and a commitment to delivering high-quality regulatory outcomes.We are seeking an...
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Director, Global Regulatory Affairs
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Waltham, MA, United States Zenas BioPharma Full timeZenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop...
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Director, Global Regulatory Affairs
23 hours ago
Waltham, MA, United States Zenas BioPharma Full timeZenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop...
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Director, Regulatory Affairs, Labeling
1 day ago
Waltham, Massachusetts, United States Alkermes Full timeDescriptionReporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject matter...
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Director, Regulatory Affairs, Labeling
13 hours ago
Waltham, MA, United States Alkermes Full timeJob Description Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject...
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Director, Regulatory Affairs, Labeling
6 days ago
Waltham, MA, United States Alkermes Full timeJob Description Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject...
