Chemistry Manufacturing and Controls (CMC) Associate/Director is responsible for working both independently and collaboratively with internal and external colleagues, partners, vendors and Regulatory Agencies to manage the Regulatory activities for all projects assigned to the CMC group for Aveo’s portfolio across the various phases of their respective lifecycles. The incumbent will also manage interactions with regulatory agencies regarding CMC matters.
Responsibilities (include, but are not limited to):
Responsibilities include but are not limited to:
- Accountable for leading robust Chemistry Manufacturing and Controls (CMC) strategy efforts and for developing and driving the local and global regulatory strategy for CMC sections in collaboration with other internal cross functional teams.
- Maintain a high-level understanding of global regulatory requirements and anticipate the impact of the changing regulatory environment on development and registration strategy. Represent Aveo with industry regulatory CMC peers.
- Effectively communicate regulatory requirements and strategy so they are fully and accurately understood by project teams.
- Provide regulatory input related to CMC strategy for inclusion into the integrated development plan to expedite development, maximize the probability of success and mitigate risks.
- Evaluate risks to submission strategy and timelines and report to management and stakeholders.
- Prepare, review, and submit high-quality regulatory documentation related to the manufacturing, testing, and release of Aveo products, INDs, CTAs, marketing applications, and related filings to regulatory agencies within established timeframes.
- Author/review key CMC documents and CMC-related sections of regulatory filings as well as briefing packages and Agency response documents.
- Monitor and report regulatory compliance of Aveo products and evaluate CMC-related change controls, deviations, and investigations and advise on the impact to submission strategy.
- Provide regulatory input into all QA policies and systems, such as QMS systems and change controls.
- Track regulatory CMC commitments and deliverables while coordinating with internal and external staff to ensure timely submissions. Interact efficiently and independently with consultants.
- Serve as CMC-focused liaison to FDA, EMA, local health authorities and other related bodies and provide leadership and support for all CMC-focused regulatory agency meetings and teleconferences.
- Initiate and contribute to the development of policies and procedures in alignment with GxPs, corporate guidance, policies, and corporate objectives.
- Other duties and responsibilities, as required.
- Bachelor’s Degree in life sciences or related discipline (advanced degree preferred)
- 7+ years biotech/pharma experience, at least 5 years of which direct experience in Regulatory CMC
- Oncology experience strongly preferred
- Track record of successful IND, CTA, NDA, and/or BLA submissions
- US and EU CMC interactions/experience preferred
- Knowledge of GxP regulations and ICH & FDA guidelines
- Hands-on, roll-up-your sleeves approach, with high sense of urgency and drive for results
- Ability to apply analytical and critical-thinking skills to enable data-driven, strategically oriented review of regulatory documents
- Effective verbal and written communication, presentation, problem-solving, and negotiation/decision-making skills
- Demonstrated proficiency using MS Office applications, including Word, Excel, PowerPoint, Project, Outlook and other relevant software or web-based applications
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of an employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
AVEO Pharmaceuticals is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO’s strategy is to focus its resources on development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO’s lead candidate, FOTIVDA® (tivozanib), received U.S. Food and Drug Administration (FDA) approval in March 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma for the treatment of adult patients with advanced RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (Anti-HGF/c-MET IgG1 mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO’s earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (Anti-ERBB3 mAb), AV-380 (Anti-GDF15 IgG1mAb) and AV-353 (Anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.
Ficlatuzumab, AV-203, AV-380 and AV-353 are investigational drugs and have not yet been approved by the U.S. Food and Drug Administration (FDA).