Regulatory Affairs Associate - One PDR

Genentech•South San Francisco, CA

29d•Onsite

About The Position

This is a temporary, 2-year contract position. Embark on a transformative two-year journey with the One Product Development Regulatory (PDR) Early Talent (ET) Program, meticulously crafted to impart comprehensive foundational knowledge in regulatory affairs. This dynamic initiative blends hands-on assignments with tailored learning solutions, making it an ideal entry-point for aspiring regulatory professionals. Participants gain invaluable insights into the complete lifecycle of pharmaceutical products, from initial clinical trials to market exit, by engaging in diverse activities across various therapeutic areas and stages of development. The latter part of the program offers the opportunity to rotate into another function or specialize further in PDR. Throughout the program, ETs collaborate with global drug development teams to support the introduction of novel pharmaceutical products to patients worldwide. This environment not only enhances their scientific writing skills but also deepens their understanding of regulatory frameworks by preparing a wide array of regulatory documents. By joining the One PDR ET Program, participants become pivotal contributors to the regulatory landscape, dedicated to ensuring that life-changing medicines reach those who need them most.

Requirements

You hold a degree (B.Sc., M.Sc., or Doctorate) in a life sciences, biological sciences, biology, chemistry, pharmacy, or related field before the start of the program, and you are within two years of completion of a degree program in the before mentioned disciplines.
You have a basic understanding of drug development and entry level understanding of the role of a regulatory professional.
You have no more than 1-year of relevant past pharmaceutical experience.
Demonstrates a learning mentality, engages in personal growth, and actively seeks and acts on feedback.
Fosters partnership, collaboration, empowerment, and autonomy to build a strong community.

Responsibilities

Delivers on projects with mentorship and actively builds foundational regulatory experience with the support of colleagues.
Owns their learning and development, actively seeking to understand drug development and regulatory roles, and engaging in knowledge sharing and peer support.
Responsible for understanding and applying business processes to deliver foundational regulatory deliverables.
Engages with the team through active listening, practicing open communication, and building trust within regulatory and cross-functional teams.
Grasps the vision of the Roche organization, understanding how their work impacts the team and contributes to overall goals.
Improves prioritization and time management skills while spending significant time on-site at Roche office.