Sr. Director, Global Regulatory Affairs
2 weeks ago
REPORTS: Vice President, Regulatory Affairs
DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024
JOB SUMMARY:
AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned programs within AVEO's portfolio. The successful candidate will be responsible for providing strategic insights and planning as well as providing guidance, and regulatory advice on compliance activities for drug and biologic development programs, as well as future commercial activities. S/he will work collaboratively across projects and cross functional teams and will provide strategic and operational leadership for regulatory activities.
The Senior Director Regulatory Affairs will work closely within the Project Management, Clinical Operations/Development, Clinical Pharmacology, and with the CMC/Technical Operations cross functional teams to ensure alignment across all departments, reaching joint deliverables and corporate goals.
PRINCIPAL DUTIES:
- Serve as the Global Regulatory Leader (GRL) for assigned oncology project(s) and be responsible for leading the development of global regulatory strategies to support the development of subcutaneous formulations, CDx, biomarker, and device development across AVEO's portfolio programs.
- Lead, plan and ensure the preparation of high-quality regulatory documents including, but not limited to, PMAs, 510(k)s, IMPD/CTA/IND, scientific advice briefing documents, orphan drug applications, PIPs/PSPs, BLA/MAA, responses to questions and other regulatory filings to support regulatory compliance and approval
- Collaborate with our CDx regulatory partners in review of documentation to support submissions
- Oversee the development and management of defining key regulatory timelines and regulatory critical path activities.
- Prepare regulatory strategies (e.g., regulatory development plans), highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments.
- Facilitate and lead all communications with Regulatory Agencies / Health Authority as applicable with the support of junior level regulatory team members for assigned projects.
- Provide expertise and guidance on global regulatory requirements, guidelines, and changes that may impact AVEO Oncology's product portfolio.
- Act as or manage delegated regulatory contact point for both internal and external stakeholders, including CROs and regulatory authorities where required.
- Evaluate various regulatory mechanisms to optimize product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, compassionate use, pediatric plans/PPSR, diversity action plans) and ensure that they are implemented, if applicable.
- Lead teams in examining regulatory strategy options, provide relevant regulatory guidance / precedents and stay abreast of the regulatory and competitive landscape.
- Serve as key corporate regulatory contact and source of regulatory information and guidance for US, LATAM, EU and Asia-Pacific markets as applicable.
- Assist in organization and management of staff in the RA group, including coaching, career development and oversight of work.
Education:
- BS or BA in a Life Sciences discipline, related field and/or equivalent experience; Advanced degree strongly desired.
- 10+ years of progressive Regulatory Affairs experience in the Life Sciences/BioTech or BioPharma industries supporting development stage programs (Phase 1-4)
- Proven experience in management and global regulatory submissions (US, LATAM, EU/UK, AsiaPac), in particular INDs/CTAs (including under new EU CTR), briefing documents, PIPs/PSPs, orphan designations and MAA/BLAs
- Proven leadership experience, including managing and developing high-performing teams.
- Strong communication skills - ability to convey multi-faceted content accurately, precisely, and persuasively to Executive Leadership Team as needed.
- Knowledge of oncology drug development, Companion Diagnostic (CDx), and Subcutaneous development
- In-depth understanding of regulations and guidelines governing all phases of drug development (for both drugs and biologics)
- Experience in achieving regulatory approval of new drugs or biologics
- Experience with electronic submission processes to Regulatory bodies, including FDA is required
- 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.
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