Associate Director/Director, Regulatory Affairs
- Job Title
- Associate Director/Director, Regulatory Affairs
- Job ID
- 27694360
- Work Hybrid
- Yes
- Location
- Boston, MA 02108
- Other Location
- Description
-
Summary
Reporting to the Vice President of Regulatory Affairs, the successful candidate will be responsible for providing strategic leadership to support the creation and implementation of global regulatory strategies to support the development of AVEO projects. The Associate Director/Director, Regulatory Affairs will manage regulatory aspects of AVEO products through all phases of investigation, post-approval and life-cycle management. S/he will work collaboratively across projects, cross functional teams and will provide strategic and operational leadership for regulatory activities including submissions, reviews, and health authority interactions. The Associate Director/Director, Regulatory Affairs will provide line management, and people development, as well as support the development and implementation of department policies.
Responsibilities (include but not limited to):- Lead the preparation, review and filing of preclinical and clinical sections of regulatory submissions and interactions with regulatory agencies
- Direct the strategy development, authoring, review, and integration of preclinical and clinical content into regulatory submissions, meeting documents, IND/CTAs, and BLA/MAA
- Oversee, coordinate and ensure the preparation of regulatory submission documentation is prepared with quality and in a timely manner to meet all agency requirements and corporate objectives.
- Maintain a centralized archive for tracking and monitoring the status of regulatory commitments and agency reporting obligations. Create and issue status reports and other communication to the organization.
- Advise AVEO’s cross functional teams with essential input on program level regulatory strategies, risk planning and mitigation, and regulatory interactions
- Lead interactions with US and international health authorities
- Represent Regulatory Affairs function for assigned projects for internal and external collaborations
- Review of clinical, pre-clinical, and labeling documents for scientific content and regulatory compliance
- Oversee the development and management of defining key regulatory timelines and regulatory critical path activities
- Provide guidance and advice on regulatory environments; provide assessment of the impact of new and changing regulations/requirements
- Prepare regulatory strategies (e.g., regulatory development plans), highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments
- Communicate effectively with employees at all levels within the organization, external partners, suppliers, regulators and others, as appropriate
- BS or BA in a Life Sciences discipline, related field and/or equivalent experience; Advanced degree strongly desired.
- 8-10 years in the Life Sciences/BioTech or BioPharma industries in Regulatory capacity with broad background.
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, developing and implementing regulatory strategies with a track record of significant regulatory accomplishments
- Excellent written and verbal communication in an international environment.
- Strong working knowledge of FDA, EMA and ICH guidelines
- 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
AVEO Oncology (“AVEO”) is an oncology-focused biopharmaceutical company committed to providing innovative solutions to improve cancer patients lives. On January 20, 2023, AVEO was acquired by LG Chem, Ltd. (“LG Chem”), establishing a U.S. commercial presence for LG Chem and expanding LG Chem’s global oncology portfolio. AVEO continues to commercialize FOTIVDA® (tivozanib) in the U.S. To learn more about FOTIVDA efficacy, safety, and relevant resources, visit FOTIVDAHCP.com.
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.
