Regulatory Program Management Specialist - Program Management

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.

Creating a world where we all have more time with the people we love.

That's what makes us Genentech, a member of the Roche Group.

The Pharma Development Regulatory (PDR) is a flexible, bold, and distinctive regulatory organization. We make decisions quickly and strategically as the environment & landscape evolves. We innovate. Within the PDR Program Management Chapter, we are responsible for delivering global regulatory strategy and end to end execution of clinical projects in the Roche portfolio, in order to develop and maintain Roche product permits/licenses to meet the needs of our patients. We deliver the regulatory components of clinical development and registration programs for products both pre- and post-licensing. We do this by developing innovative and effective global regulatory strategies, assessments and plans and support documentation in collaboration with regional regulatory affairs counterparts, cross functional product teams, corporate partners and global health authorities, based on current regulatory knowledge and expertise.

As a Regulatory Program Management Specialist in the Program Management Chapter, you will support global Health Authority interactions and procedures, represent regulatory affairs on cross-functional project teams and ensure the consistent and safe use of our medicines through high-quality labels. Additionally, you understand how data and information contribute to the quality of our submissions.

We are eager to welcome dynamic and curious individuals to our Global Regulatory Program Management organization at our South San Francisco, CA site.

• Contribute to the development and implementation of regulatory strategies and risk mitigations to facilitate the development, approval and life cycle management of Roche product permits/licenses

• Participate in discussions and contribute to interpreting the needs of worldwide evolving pharmaceutical regulations

• Support gathering of regulatory intelligence necessary to generate, interpret and present insights that meets the needs of health authorities, patients, purchasers and prescribers for Roche's global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing

• Coordinate the timely submission of applications to/interactions with health authorities for approval of clinical trials, new products and line extensions

• Coordinate successful issue management

• Degree in Life Sciences or equivalent with 1- 3 years of relevant experience in the pharmaceutical/biotechnology industry, including independent project delivery and leadership.

• Strong computer skills across G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault.

• Working knowledge of regional/global drug development processes, regulations, and guidelines (GxP, GCP, ICH) and an understanding of GVP and GCP principles including data integrity.

• Strong interpersonal abilities, effective collaboration in cross-functional and matrix-based environments, and fluency in English (verbal and written).

• Ability to work under minimal supervision, detail-oriented with excellent administrative and project planning skills, curiosity, adaptability to change, and proactive learning.

Our team follows a hybrid work structure (majority of days on-site is required).

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 $97,700 - 181,500. 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.