AbbVie
Location
South San Francisco, CA | United States
Job description
We are currently seeking a Regulatory Affairs Associate Director to join our growing regulatory team. In this role you would be the Global Regulatory Lead where you will develop and implement global regulatory strategies to support the development of multiple oncology early development assets, contributing to the advancement of leading edge cancer research in a nimble, biotech like environment within a large, well established pharmaceutical company. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross - functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. This position is based at AbbVie in the South San Francisco, CA location.
Key Responsibilities:
· Serve as the Global Regulatory Lead on project teams and key sub-teams
· Develop and implement competitive and effective global regulatory strategies for oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
· Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes
· Collaborate with AbbVie regional and country regulatory affiliates to support ex-US clinical development activities
· Present Regulatory strategies and issues at team and governance meetings
· Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and Health Authority reviewers
· Prepare teams for and lead Health Authority meetings
· Manage and participate in the creation, review, assembly and submission of regulatory documentation including INDs and CTAs and amendments, RFIs, annual reports
· Ensure consistency/completeness/adherence to standards for all regulatory submissions
· Coordinate and consult with other departments on the content, review of publication materials, and assembly of regulatory documentation
· Support non-program specific projects as assigned such as department initiatives, business development assessments, clinical assessments, and department training, etc.
Qualifications:
· Bachelor degree in a life sciences, chemistry, or related discipline. Advanced degree preferred.
· Associate Director - 5 – 7 years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required. Director - 7-10 years of experience in Regulatory Affairs plus 3-5 years proven experience in a leadership role with strong management skills.
· Demonstrated understanding of regulations and guidelines governing oncology drug development and ability to strategically apply to overall drug development
· Demonstrated leadership ability in team settings
· Strong written and verbal communication skills
· Demonstrate expertise and knowledge of oncology and relevant indications
Key Leadership Competencies:
· Builds strong relationships with peers and with partners cross functionally outside of team to enable higher performance
· Learns fast, grasps the 'essence' and can change the course quickly where indicated
· Raises the bar and is never satisfied with the status quo
· Creates a learning environment, open to suggestions and experimentation for improvement
· Embraces the ideas of others, nurtures innovation and manages innovation to reality
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
Job tags
Salary
