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The Position
About Roche Pharma Technical Regulatory
In response to our Pharma Vision, the PT promises and our PTR North Star, PTR is striving to become more flexible, efficient and faster to deliver on our important mission to develop and maintain our licenses and to influence HA in their thought process to ultimately achieve ‘one submission, one approval, for patients worldwide’. We are doing this by creating an operation model that supports flexible talent flow and by building our capabilities as regulatory experts leading ultimately to the ability to quickly meet our business needs.
This Job is an Individual Contributor position. A regulatory professional in PTR constantly broadens their understanding of the regulatory landscape and applies their knowledge in the execution of deliverables aligned with our North Star.Regulatory professionals are encouraged to change and boldly innovate, collaborate and create outcomes that matter for patients, stakeholders and the company.
Your responsibilities may include a wide variety of contributions: partnering with key stakeholders, working on the molecule and non-molecule portfolio, collaborating with affiliates and partnering with the Policy team to influence HAs or contributing to key initiatives that shape our technical business and healthcare environments. Everyone in PTR has a role in creating an environment in which every member of our organization can thrive. To maintain our License to Operate in a highly regulated industry, GxP compliance and adherence to the Roche Group Code of Conduct are every employees responsibility. This includes ensuring that you have the appropriate training, experience, and qualifications necessary to perform and complete your work in accordance with regulatory requirements, and corporate policies and standards.
Commonalities for Project and Portfolio Management Professionals
● Responsible for supporting PTR in the implementation of regulatory strategies and filing plans for high quality CMC regulatory documents delivery to health authorities globally according to current Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.
● Actively contribute to the success of PTR’s Strategic Focus areas (SFAs) and technical regulatory team objectives and the timely regulatory approval of Roche products.
● Ensure cross-functional PTR deliverables are completed compliantly, accurately, thoroughly and in a high quality and timely manner.
● Contribute to regulatory and operational excellence by identifying opportunities for efficiency gains, mitigating risks and enabling continuous improvement (i.e. in processes, systems, technology, innovation).
● Support review or creation of departmental business processes (e.g. submissions execution), align processes and tools and implement success criteria and metrics to track and improve work efficiencies.
● Understand how regulatory data flows within our systems environment, help embed a data culture, train PTR users in maintaining high data quality, compliance and accuracy, and support critical regulatory data and insights delivery to committees, leaders and stakeholders for planning, prioritization and decision making.
Roles and Responsibilities
● Partner with regulatory professionals in the planning and execution of regulatory submissions across the product lifecycle in RIM. Support the One Regulatory Network (ORN) in the sustainment of our regulatory workflow and regulatory system applications beyond RIM.
● Accountable for delivering high quality project and portfolio management formulating risk mitigation strategies and ensuring project completion within approved timelines and budgets. Drive project and portfolio success by having an enterprise mindset, adopting agile ways of working and effectively managing change and ambiguity.
● Responsible for leading, planning or delivering cross-functional initiatives and regulatory submissions with knowledge of emerging regulatory guidelines.Foster knowledge sharing and proactively contribute to a teach-and-learn culture to support the success of others and the department.
● Support reporting processes, KPIs and implementation. Aggregate regulatory data to analyze and deliver actionable insights to support discussions on prioritization, operational tracking, cross product trends, regulatory risk evaluation, HA QnA, submission process improvements, regulatory reliance, speed to market, etc.
● Display growth mindset in learning new regulatory activities and understanding submission processes in RIM to grow regulatory knowledge and enable work sharing within squads. Independently lead or support SMEs in regulatory activities alongside the regulatory product portfolio team.
● Contribute to the upskilling and capability building of others within and outside of the group through appropriate mentoring and/or training activities.
Competencies and Skills
● Understands and applies in-depth knowledge of Roche and regulatory guidelines, project and portfolio management procedures and industry best practices.
● Leads by applying knowledge in these areas (project and portfolio management, regulatory business processes, systems and tools, agile, change management) to the strategic product and non-product portfolio at the organizational or enterprise level.
● Facilitates translation of strategy into clear and measurable project outcomes with clear cross functional and stakeholder alignment. Develops and presents business cases, builds these capabilities in others and delivers recommendations based on data analysis and insights.
● Able to build and maintain productive and trusted relationships within/across departments as well as with external partners and regulators.
● Support strategic planning of regulatory submissions, stays abreast of internal and external developments and understands required laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics. Follows regulations and company policies, and complies with all Roche Business Processes.
● Demonstrates a continuous improvement mindset by:
○ Identifying and recommending opportunities to streamline or improve processes, systems, and tools.
○ Actively seeking feedback on self and providing feedback on others
This position is permanent.
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Who we are
At 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 at Penzberg, near Munich, employs more than 7,000 people. The site is one of the largest biotechnology centers in Europe and the only Roche site with research, development and production for both Pharmaceuticals and Diagnostics under one roof. From your beginning with Roche, our motivated team will welcome and support you. Numerous opportunities for personal development, flexible work hours, attractive compensation packages and special family assistance programs are available.
Roche is an Equal Opportunity Employer.