Regulatory Program Management Specialist – Labeling

Job title: Regulatory Program Management Specialist – Labeling

Company: Roche


Job description: Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionA 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 Roche.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.We are looking for a Regulatory Program Management Specialist – Labeling to join our team for a 1 year fixed term contract.The OpportunityContribute 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 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.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 areBachelor’s degree with 3 years of proven experience in current therapeutic area focus in PD Regulatory Program ManagementUnderstand 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. Recognize 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.Relocation Benefits are not available for this job posting.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche’s truly innovative culture.As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.Roche is an Equal Opportunity Employer.

Expected salary:

Location: Mississauga, ON

Job date: Sun, 10 Nov 2024 23:34:33 GMT

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