Labeling Team Leader

The PD Regulatory Program Management Chapter is committed to providing comprehensive global regulatory strategies and leading all aspects of the end-to-end execution of clinical projects within the Roche portfolio, with the goal of developing and maintaining product permits/licenses to serve patient needs. Members of this chapter are tasked with leading the regulatory components of clinical development and registration programs for products, both pre- and post-licensing. This is achieved through the creation of innovative and effective global regulatory strategies, assessments, plans, and supporting documentation. These efforts are made in collaboration with regional regulatory affairs counterparts, cross-functional product teams, corporate partners, and global health authorities, demonstrating up-to-the-minute regulatory knowledge and expertise.

Internally this role is known as a Regulatory Program Management Professional / Specialist - Labeling.

This Job is a Leader position. Our leaders are accountable for advocating and driving changes throughout the organisation and support our people in a matrixed environment. With a thorough understanding of priorities and areas of high impact, PDR leaders connect the right people and resources with the right work, and help the organisation adapt to evolving regulatory requirements.

• Lead 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 labeling requirements.

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

• Lead company documents and responses to Health Authority requests related to product labeling, 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.

• Partner with key stakeholders, work on the molecule portfolio, and lead key initiatives that shape Roche's technical, business, and healthcare environments, ensuring alignment with organizational goals and innovative solutions.

• Maintain Roche's License to Operate by ensuring all labeling activities adhere to regulatory requirements and corporate policies, including medical compliance and adherence to the Roche Group Code of Conduct.

• Keep informed about internal and external developments, trends, and the competitive landscape relevant to Roche/Genentech products, allowing for proactive and informed regulatory decision-making.

• Lead the development and implementation of new or updated Regulatory and Labeling specific Standard/Department Operating Procedures (SOPs/DOPs), systems, and processes crucial for content creation and tracking, ensuring end-to-end labeling compliance.

• Demonstrated ability to work pragmatically with complex & ambiguous situations - Applies understanding of environmental changes and precedents to navigate complex situations and influence strategies and decision making.

• Mindful stewardship of Regulatory resources, promoting effective prioritization and planning for future impact.

• Effectively influences peers, leaders, and stakeholders inside and outside of PDR needs.

• You have a bachelor's degree with 7 years experience in current therapeutic area focus in PD Regulatory Program Management

• You understand and demonstrate your own expertise while developing insight into the external regulatory environment.

• Apply creative thinking to contribute to documents, strategic proposals, and a broader range of results. Recognise the impact of contributions to the PD Regulatory Chapter and actively share insights and knowledge to improve team performance.

• Establish trustful and open relationships with key stakeholders, collaborate effectively to deliver specific PD Regulatory deliverables, and seek different perspectives to evolve ideas.

• Approach work with curiosity, adapt to change, and proactively seek learning opportunities. Understand the importance of Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) principles and data integrity, ensuring high standards are maintained in all regulatory activities while applying PDR advice-seeking principles to informed decision-making processes.

This role is based in the SSF office. Please upload only your current compelling CV and / or Cover Letter.

We look forward to receiving your application!

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 $155,600 - $289,000. 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.