Director, Regulatory Operations Hybrid/Waltham

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Our proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs).Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.This is your chance to be part of the company with the first mAb authorized in over a year and the only one currently on the market for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kg) with moderate-to-severe immune compromise.Be part of making a difference. Be part of Invivyd.Job Title: Director, Regulatory OperationsThe Director will be responsible for successfully leading, directing, and monitoring the daily activities required in the execution of global marketing application submission projects, process improvement, and transition projects from planned development through completion. This position will lead the Veeva Vault RIM Suite continuous improvement and assist with additional Veeva implementations. Success in this role will require a thorough and current understanding of appropriate FDA and ICH regulations pertaining to global regulatory and technical requirements for documents of all submission dossier types, including Word document format, PDF specifications, and CTD structure and compliance, with full awareness of a global environment, and a robust knowledge of regulatory information management systems, as well as providing Regulatory Operations leadership in staff oversight, various corporate initiatives, finance, and budgeting.Responsibilities:Responsible for leadership, accountability, and oversight for active programs and projects with a proven understanding of IND, CTA, BLA, and MAA processes for initial applications, post-marketing commitments, and lifecycle management for all submission types as they pertain to internal and external commitments that include submission planning, timelines, document preparation, global submission activities, and archival processes.Proven leadership and expertise in all aspects of formatting, publishing, version control, and quality control of Word and PDF documents during draft and final document team reviews with full knowledge of global document specifications per ICH and FDA guidance.Lead the tracking of BLA and MAA publishing content plans and document deliverables with the ability to strategically delegate appropriately to meet submission deadlines.Lead Veeva RIM Suite continuous improvement and roll-out to cross-functional teams.Author job aids with step-by-step tasks and processes associated with document approvals, workflows, searching, archiving, commitments, running reports, submission tracking, metrics, and additional aspects of the capabilities of the Veeva RIM Suite platform.Provide Regulatory Operations User requirements and recommendations during auto releases and out of cycle configurations.Lead SOP updates that align with auto releases, configurations, and process improvement updates.Lead issue and resolution management with Users and Veeva Managed Services.Provide Regulatory Operations leadership during the implementation process of Veeva PromoMats in preparation for eCTD submissions to OPDP.Encourage and maintain a strong interface with Regulatory staff, facilitating and prioritizing the development of compliant submissions.Work through complex situations across functional areas and identify issues that may delay timelines while recommending appropriate action through strategic decisions and recommendations.Set clear objectives and consistently deliver while demonstrating full accountability for functional area results.Assist Regulatory Operations with financial and budgeting support for annual and long-range planning.Provide expertise while participating in assigned corporate leadership initiatives in various aspects of business process improvement.Requirements:Bachelor’s degree and/or Master’s degree with a minimum of 10 years relevant experience in pharmaceutical/biotechnology Regulatory Operations and project management.Proven leadership oversight for IND, CTA, BLA, MAA marketing applications, lifecycle management, and post-marketing submission types.Must be flexible as an individual contributor providing hands-on formatting and publishing support, simultaneously with the leadership requirements in this dual role.Must have superior quality control document review skills for Word and PDF with the ability to identify, communicate, and train on inconsistencies that align with Invivyd's processes.Precise document tracking management over multiple products is essential for success in this role.Must be detail-oriented, decisive, and capable of influencing individuals and managing teams while demonstrating leadership, flexibility, and strong communication and negotiation skills in a fast-paced environment with constant change and diversity.Proven leadership on overall operational planning, coordination, and support of compliant submission dossier publishing activities with the ability to develop and manage publishing timelines for the compilation of submission and maintenance of regulatory filings.Articulate with strong analytical, ethical decision-making, sound judgment, problem solving, and interpersonal skills while communicating with internal and external stakeholders.Must have the ability to present a positive and professional image through communication and interaction with key stakeholders, including colleagues, customers, vendors, and appropriate regulatory authorities, with the adeptness to work autonomously and effectively manage time to deliver results within defined timelines.Proven success in demonstrating leadership style that incorporates independent decision making, technical proficiency, creativity, and collaboration with team members.Knowledgeable in financial planning that defines FTE, contracts, and fees assumptions.Expert skills in MS-Office Suite, Adobe Acrobat and plug-ins, SharePoint, and Veeva RIM Suite.At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.Invivyd is proud to be an equal opportunity employer.

#J-18808-Ljbffr