Location: New York,NY, USA
The Sr. Manager, Regulatory Operations, plays a pivotal role in ensuring the seamless coordination of regulatory submission activities after document content is finalized. Working within a dynamic regulatory team, this individual will be responsible for managing the end-to-end process of document-level publishing, submission assembly, compliance review, and document management/archive, as well as overseeing the maintenance and enhancement of systems critical to regulatory operations. A Veeva Systems expert, the Sr. Manager will lead the implementation, optimization, and continued support of Veeva systems for regulatory document management and compliance tracking. The Sr. Manager will work collaboratively with the Regulatory Affairs and Medical Writing team along with project teams and other functional areas to ensure high-quality submission content.
Lexeo has a hybrid work culture but is open to remote candidates within the US for this role.
Primary Responsibilities
* Oversee the organization, review, and maintenance of documents for regulatory submissions, ensuring accuracy, consistency, and adherence to regulatory requirementsand compliance with local and regional registration requirements as well as with company policies.
* Implement and maintain archiving strategies to support long-term record-keeping and regulatory compliance, including organizing and categorizing records within Veeva.
* Compile regulatory documents into compliant submissions, ensuring all materials are formatted correctly and meet FDA, EMA, and other relevant agency standards.
* Publishes electronic submissions in Electronic Common Technical Document (eCTD) for FDA. This may include source document formatting, internal and external hyperlinking,bookmarks and sequence-level publishing.
* Manage document readiness and finalization, coordinating with internal stakeholders to assemble, review, and finalize submissions in alignment with project timelines.
* Support literature management and assembly as part of submission preparation.
* Establish and manage submission tracking processes, ensuring that submission statuses are accurately maintained and communicated to relevant stakeholders.
* Develop and implement tracking dashboards or reporting tools to provide real-time updates on submission progress and maintain visibility for project teams.
* Develop and administer in-house training, as needed, to ensure optimal use of templates, processes, and tools critical to compiling submissions
* Organize, track, and maintain submission components associated with regulatory submissions. This may include, but not exclusive to, setting up templates, printing, and maintaining records/data in the Regulatory Information Management (RIM) system.
* Coordinate and track delivery of required content with content owners for routine/maintenance submissions
* Provide advice on acceptability of regulatory submission plans, from a Regulatory Operation perspective
* Provide support in software validation/migration/updates specific to systems in Regulatory Affairs. Support the implementation, maintenance, and continuous improvement of authoring and publishing systems and processes striving for publishing excellence.
* Act as the System Administrator (superuser) for Veeva RIM within Regulatory Operations, driving system implementation, customization, SOP development, and continuous improvement. Specifically:
* Creates, uploads, and versions documents in the Veeva RIM vault.
* Create and manage binders using Veeva RIM.
* Uploads submissions to the submission archive in Veeva RIM.
* Provide ongoing training, troubleshooting, and support for Veeva users within regulatory and cross-functional teams to ensure system alignment with business needs.
* Collaborate with publishing vendors to manage submission timelines, ensure quality standards, and address submission requirements promptly.
* Maintain vendor relationships, serving as the regulatory operations point of contact and ensuring vendors meet company and regulatory expectations for submission quality.
* Monitors global health authority regulations, guidelines, and specifications relevant to publishing and submissions including FDA, EMA, Health Canada, and ICH, as required, to ensure compliance
* Continuously develop and update knowledge of relevant regulatory requirements, guidance documents, and submission standards to support effective submission preparation.
* Keeps abreast of regulatory procedures and changes. May directly interact with regulatory agencies on defined matters.
* Contribute to development of process documentation including, SOPs, Work Instructions, or Best Practices
* Act as a liaison between regulatory operations and cross-functional stakeholders to address regulatory needs, ensure alignment on submission objectives, and communicate regulatory timelines.
* Facilitate communication between regulatory teams and other departments to ensure seamless submission and compliance processes.
* Assist in audit preparation by organizing documentation, ensuring regulatory submissions are audit-ready, and representing regulatory operations during inspections as needed.
Required Skills & Qualifications
* Bachelor's degree in a scientific, technical, or regulatory-related discipline required.
* 8 - 10 years of experience in regulatory operations within the pharmaceutical or biotechnology industries, with a demonstrated track record in document and submission management.
* Extensive experience with Microsoft Word and StartingPoint templates to prepare technical documents.
* Proficient in migration to and maintenance of Veeva RIM. Expertise in Veeva implementation, customization, and support, including the ability to troubleshoot issues, train users, and drive process improvements.
* Understanding of publishing practices and related issues.
* Strong knowledge of FDA submission requirements, document formatting standards, and regulatory guidelines (FDA, EMA, ICH) to support submission accuracy and compliance.
* Proven ability to manage complex submissions, multitask, and meet tight deadlines.
* Experience with project planning tools and tracking systems to effectively coordinate regulatory timelines and maintain submission documentation.
* Excellent written and verbal communication skills, with a strong ability to clearly convey regulatory information to cross-functional teams.
* Ability to collaborate effectively with internal and external stakeholders and foster productive relationships with publishing vendors.
* Detail-oriented with a high standard of quality for regulatory submissions and document tracking.
* Strong analytical skills for troubleshooting issues within regulatory systems and ensuring submission quality.
* Demonstrated ability to be productive and successful in a fast-paced work environment.
$134,000 - $180,000 a year
Base salary dependent on qualifications and overall experience.
About Lexeo
Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer's disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of clinical and preclinical programs. Lexeo successfully completed a $112M IPO in November 2023 and in early March announced a PIPE raising an additional $95M, extending the Company's runway into 2027.
Our work culture for most roles is a hybrid model with days in the New York City office and days working from home. We welcome applications from candidates located across the Northeast and Mid-Atlantic. Remote work can be considered for exceptional candidates.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.