Hybrid is highly preferred but Open for Remote for the right person
MUST Required
- Global Regulatory Affairs experience is needed
- Oncology/Cancer Experience is needed
Job Description
We are currently seeking a Regulatory Affairs Associate Director/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.
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 Client 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 documents 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
Skills/Qualifications Required
- Bachelor’s degree in a life sciences, chemistry, or related discipline. Advanced degree preferred.
- 5 – 7 (Director)/ 7 – 9 (Associate Director) 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.
- Demonstrated understanding of regulations and guidelines governing oncology drug development and ability to strategically apply to overall drug development
- Demonstrate expertise and knowledge of oncology and relevant indications
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity,
national origin, disability, or status as a protected veteran.
