What are the responsibilities and job description for the Director/ Sr, Director, Regulatory Affairs-Commercial position at Page Mechanical Group, Inc.?
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 AVEO's 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 objectives.
- Develop 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
REQUIRED QUALIFICATIONS / EXPERIENCE (BASIC QUALIFICATIONS) :
Education :
Experience :
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.
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