Fusion Pharmaceuticals
Sr. Manager, Regulatory Operations (Submissions, Publishing)
Fusion Pharmaceuticals - Everett, Massachusetts, us, 02149
Work at Fusion Pharmaceuticals
Overview
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Overview
Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes but is not limited to: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. Fusion has multiple other pipeline programs that will soon be entering into early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radioconjugate manufacturing facility to meet supply demand for our growing pipeline of RCs.
All candidates should make sure to read the following job description and information carefully before applying.
Position Summary : Fusion has opened a newly created role for a Senior Manager, Regulatory Operations (Submissions, Publishing and Management). The successful candidate will oversee the planning, management, and execution of regulatory submissions, ensuring high-quality dossiers that meet global regulatory standards. We are seeking someone experienced with the Veeva platform and its integration with other systems. Acting as a strategic partner and conduit between cross-functional teams, this individual will streamline submission and publishing processes and drive continuous improvement in tools, templates, and SOPs. With a focus on collaboration and excellence, this role is pivotal in ensuring timely, accurate submissions that align with organizational objectives and regulatory requirements. This role will report to the Vice President, Head of Regulatory Affairs.
Requirements : • Establish and execute Regulatory Operations strategies aligned with company goals. • Oversee submission planning, management, and timely delivery of regulatory dossiers. • Serve as the primary Regulatory Operations Lead, collaborating with Regulatory Strategy to develop and manage submission timelines and processes. • Establish, train, and implement submission processes with internal teams and external partners. • Develop, review, and approve Regulatory Operations SOPs and governing documents. • Track submission timelines and ensure clear communication across global programs. • Oversee global submission preparation, timelines, distribution, and archiving, ensuring compliance with regulatory standards. • Manage and support Veeva platforms, and its integration into other systems as needed. • Serve as Submissions Manager for projects across the USA, EU, and other regions, collaborating on strategy and content planning. • Perform QC on all major regulatory submissions before filing with the respective Regulatory Authority. • Lead cross-functional meetings on submission planning for clinical, non-clinical, and CMC programs. • Drive continuous improvement on all Regulatory submission planning and execution related tools and templates. • Coordinate with medical writers and SMEs on regulatory submission documents (e.g., RTQs). • Train staff and serve as SME on regulatory systems, processes, and requirements. • Liaise with global regulatory CRO teams to ensure complete CTA packages and submissions. • Identify and troubleshoot regulatory gaps, conflicts, or process delays. • Manage document collection and respond to CRO requests related to submissions. • Oversee vendors handling submission publishing activities.
Qualifications : • Bachelor’s degree in a scientific discipline required; advanced degree preferred and a minimum of 8 years in Regulatory Operations, Submissions Management, or related roles involving regulatory interpretation and eCTD submission compilation. • Strong experience with USA and EU submissions across multiple submission types. • Expertise in global eCTD standards and submission formats, with proficiency in publishing platforms (e.g., DocuBridge) and document management systems (e.g., Veeva). • High familiarity with FDA CFR, regulatory guidance interpretation, and tracking regulatory changes impacting submissions. • Strong organizational skills with the ability to manage multiple large-scale projects simultaneously. • Ability to work in a fast-paced, dynamic environment, handling aggressive timelines while maintaining composure under pressure. • Strong analytical skills with a high level of integrity in managing proprietary and confidential information.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
PDN-9e532765-3ce5-4966-84e8-c544b600fc75
All candidates should make sure to read the following job description and information carefully before applying.
Position Summary : Fusion has opened a newly created role for a Senior Manager, Regulatory Operations (Submissions, Publishing and Management). The successful candidate will oversee the planning, management, and execution of regulatory submissions, ensuring high-quality dossiers that meet global regulatory standards. We are seeking someone experienced with the Veeva platform and its integration with other systems. Acting as a strategic partner and conduit between cross-functional teams, this individual will streamline submission and publishing processes and drive continuous improvement in tools, templates, and SOPs. With a focus on collaboration and excellence, this role is pivotal in ensuring timely, accurate submissions that align with organizational objectives and regulatory requirements. This role will report to the Vice President, Head of Regulatory Affairs.
Requirements : • Establish and execute Regulatory Operations strategies aligned with company goals. • Oversee submission planning, management, and timely delivery of regulatory dossiers. • Serve as the primary Regulatory Operations Lead, collaborating with Regulatory Strategy to develop and manage submission timelines and processes. • Establish, train, and implement submission processes with internal teams and external partners. • Develop, review, and approve Regulatory Operations SOPs and governing documents. • Track submission timelines and ensure clear communication across global programs. • Oversee global submission preparation, timelines, distribution, and archiving, ensuring compliance with regulatory standards. • Manage and support Veeva platforms, and its integration into other systems as needed. • Serve as Submissions Manager for projects across the USA, EU, and other regions, collaborating on strategy and content planning. • Perform QC on all major regulatory submissions before filing with the respective Regulatory Authority. • Lead cross-functional meetings on submission planning for clinical, non-clinical, and CMC programs. • Drive continuous improvement on all Regulatory submission planning and execution related tools and templates. • Coordinate with medical writers and SMEs on regulatory submission documents (e.g., RTQs). • Train staff and serve as SME on regulatory systems, processes, and requirements. • Liaise with global regulatory CRO teams to ensure complete CTA packages and submissions. • Identify and troubleshoot regulatory gaps, conflicts, or process delays. • Manage document collection and respond to CRO requests related to submissions. • Oversee vendors handling submission publishing activities.
Qualifications : • Bachelor’s degree in a scientific discipline required; advanced degree preferred and a minimum of 8 years in Regulatory Operations, Submissions Management, or related roles involving regulatory interpretation and eCTD submission compilation. • Strong experience with USA and EU submissions across multiple submission types. • Expertise in global eCTD standards and submission formats, with proficiency in publishing platforms (e.g., DocuBridge) and document management systems (e.g., Veeva). • High familiarity with FDA CFR, regulatory guidance interpretation, and tracking regulatory changes impacting submissions. • Strong organizational skills with the ability to manage multiple large-scale projects simultaneously. • Ability to work in a fast-paced, dynamic environment, handling aggressive timelines while maintaining composure under pressure. • Strong analytical skills with a high level of integrity in managing proprietary and confidential information.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
PDN-9e532765-3ce5-4966-84e8-c544b600fc75