Global Regulatory Lead

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 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

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.

5 – 7 (assoc dir)/ 7 – 9 (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

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, opens to suggestions and experimentation for improvement

Embraces the ideas of others, nurtures innovation and manages innovation to reality

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, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.