Regulatory Labeling Manager

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

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.

The Opportunity

We are looking for a Regulatory Program Management Specialist - Labeling to join our team.

In this position you will:

• 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 labeling requirements.

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

• Lead or contribute to 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 contribute to key initiatives that shape Roches technical business and healthcare environments ensuring alignment with organizational goals and innovative solutions.

• Maintain Roches 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.

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

Who you are

• You possess a Bachelors degree and at least three years of proven labeling experienceincluding CDS EU and US labelswithin your current therapeutic area and PD Regulatory Program Management. You bring deep insight into regulatory affairs specifically in strategic labeling backed by a comprehensive set of technical skills and industry knowledge. Furthermore while your core expertise lies in regulatory standards any additional experience you have in market access is considered a distinct advantage.

• You understand and demonstrate your own technical expertise while actively developing deep insight into the evolving external regulatory environment. Your project management skills allow you to achieve multiple tasks consistently and goals on-time

• You apply creative thinking to contribute to strategic proposals and high-impact documents recognizing how your contributions benefit the PD Regulatory Chapter while sharing knowledge to elevate team performance.

• You establish trustful open relationships with key stakeholders and collaborate effectively to deliver regulatory requirements while seeking diverse perspectives to evolve ideas.

• You have proven ability to lead cross-functional matrix teams with strong influencing skills.

• You approach work with curiosity adapt to change and proactively seek learning opportunities. You 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.

Scientific rigour and creativity inclusive teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together we can be transformative.

If you are passionate about contributing to a committed team and have the dedication to partnership and innovation Roche is the place for you!

Every role at Roche plays a part in making a difference in patients lives.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.