Regulatory Program Management Specialist - Labelling

At Roche, everything we do is rooted in our purpose: creating a healthier future for generations to come. We are driven by science, inspired by patients, and committed to making more time for the moments that matter.

We're looking for a Regulatory Affairs Professional to join our Product Development Regulatory (PDR) team, specialising in labelling. In this pivotal role, you'll contribute to the development and lifecycle management of medicinal products by crafting high-quality regulatory labelling strategies and documentation that serve both patients and healthcare professionals around the world.

• Contribute to the global product team in crafting and maintaining the company Core Data Sheet (CDS), core Patient Product Information (cPPI), and key local product labels for the EU and US throughout the lifecycle of pharmaceutical products and devices, ensuring compliance with labelling requirements.

• Apply critical thinking and effective data messaging in the creation and maintenance of regulatory labelling documents, ensuring clarity and accuracy in product information.

• Lead or contribute to company documents and responses to Health Authority requests related to product labelling, facilitating clear communication and compliance with regulatory standards.

• Guide the product team and country affiliates in the implementation of CDS updates to local labels, ensuring consistency and adherence to global regulatory requirements

• Support the development of SOPs and systems for regulatory labelling to ensure end-to-end compliance throughout the product lifecycle

• Stay up to date with evolving global regulations, competitive landscapes, and internal policies to inform strategic labelling decisions

• You hold a Bachelor's degree and bring experience in regulatory affairs, preferably with a focus on labelling

• You're well-versed in Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP)

• You think critically, communicate clearly, and balance regulatory compliance with scientific and patient-centric thinking

• You thrive in a collaborative environment, building trust and sharing insights across global teams

• You're curious, adaptable, and eager to continuously learn in a fast-paced, purpose-driven organisation

Ready to shape the future of global product labelling? Apply now and join us as our next Regulatory Program Management Specialist - Labelling

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $118,400 - 219,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.