Director/ Sr, Director, Regulatory Affairs-Commercial
 AVEO Pharmaceuticals | |
 United States, Massachusetts, Boston | |
| 30 Winter Street (Show on map) | |
 Jan 13, 2025 | |
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JOB TITLE: Director/Sr. Director, Regulatory Affairs - Commercial
DEPARTMENT: Regulatory Affairs REPORTS TO: Vice President, Regulatory Affairs LOCATION: Boston MA DATE PREPARED: January 13, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Director/Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of our commercial product FOTIVDA. The successful candidate will be responsible for providing strategic insights and planning as well as providing guidance, and regulatory advice on activities related to advertising and promotion for the marketed product, as well as regulatory strategies for future commercial activities with corporate partners. S/he will work collaboratively with the assigned commercial project team and will provide strategic and operational leadership for regulatory activities. The Director/Senior Director, Regulatory Affairs will work closely with the FOTIVDA Project Lead, Marketing team and Commercial organization to ensure alignment and reaching joint deliverables and corporate goals. PRINCIPAL DUTIES: Advertising and Promotion * Serves as the regulatory lead on AVEOs Marketing Review Committee (RC) who will collaborate with AVEO Marketing, Commercial, Compliance/Legal, and Medical Affairs to competitively position FOTIVDA appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices. * Responsible for the review and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives. * Support the US commercial teams, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. * Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with U.S. promotional regulations, corporate standards and policies and business objective * Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating and managing business risks. * Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives * Assist on the development of US labeling to ensure support for anticipated promotional messages and claims * Monitor OPDP/APLB research, guidance and enforcement activities, assess impact and communicate learnings to stakeholders Commercial * Lead the development of regulatory strategies and risk mitigation plans for FOTIVDA commercial product. * Collaborate with cross-functional teams to support product approvals and submissions outside the US with corporate partners, and maintain product filing within the US. * Manage global regulatory marketing applications with corporate partners, ensuring consistency across regions. * Leads the development and management of project plans and timelines and assigns and manages resources effectively to ensure all projects are appropriately prioritized and key goals are met on time * Responsible for development of global core data sheet and updates to the approved package insert globally. * In interacting with the Health Authorities, the individual will lead and/or participate in meetings with Global Health Authorities (HAs) as appropriate. * Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards. * Develop SOPs and working instructions to ensure high performing commercial regulatory operations and effective review processes. REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS): Education: * BS or BA in a Life Sciences discipline, related field and/or equivalent experience; Advanced degree strongly desired. Experience: * 12 years of progressive Regulatory Affairs experience in the Life Sciences/BioTech or BioPharma industries supporting Advertising and Promotion Activities and Commercial Development, with at least 7 years' experience in a regulatory leadership role. * Proven experience in management of post-approval activities for global regulatory submissions (US, Canada, LATAM) * Proven leadership experience, including managing and developing high-performing teams. Skills: * Strong communication skills - ability to convey multi-faceted content accurately, precisely, and persuasively to Executive Leadership Team as needed. * Knowledge of oncology drug development preferred * Experience in achieving regulatory approval of new drugs or biologics * Experience with electronic submission processes to Regulatory bodies, including FDA is required * Experience with Veeva RIM and Veeva PromoMats * Excellent verbal and written communication skills including presentation skills About AVEO AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company. 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. | |