Regulatory Strategy Senior Leader

12-15 years

Not Disclosed

Basel

10 April 28, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Strategy Senior Leader
Location: Basel, Basel-City, Switzerland
Category: Regulatory Affairs
Job ID: 202503-107688

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

About Roche Product Development Regulatory (PDR)

We are a flexible, bold, and distinctive regulatory organization. We make decisions quickly and strategically as the environment & landscape evolve. We innovate. Our communities form a culture where I, YOU, and WE learn continuously. We deliver insights to the Roche organization. We apply these insights to develop our portfolio effectively and efficiently. We employ our unique strengths through a strong sense of purpose to create medical advances for society. We thrive as a community while enjoying fulfilling work and meaningful careers. We trust and rely on each other. We try new approaches. We openly discuss and learn from our mistakes and failures. We experiment and iterate to achieve our aspirations. I, YOU, and WE feel pride in the impact we make together for patients.

About this Chapter in PDR

The PD Regulatory Program Management Chapter is accountable and 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 licenses to meet the needs of our patients. Chapter members deliver the regulatory components of clinical development and registration programs for products both pre-and post-licensing. Chapter members do this by developing innovative and effective global regulatory strategies, assessments, plans, and supporting documentation in collaboration with regional regulatory affairs counterparts, cross-functional product teams, corporate partners, and global health authorities, based on up-to-the-minute regulatory knowledge and expertise. Chapter members lead and 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.

This Job is a Leader position. A Leader in PDR has a broad understanding of the regulatory landscape and applies their knowledge in the execution of deliverables aligned with our True North. Our leaders are accountable for advocating and driving changes throughout the organization 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 organization adapt to evolving regulatory requirements. You will inspire all of our people to boldly innovate, collaborate, and create outcomes that matter for patients, stakeholders, and the company. To maintain our License to Operate in a highly regulated industry, medical compliance and adherence to the Roche Group Code of Conduct are every employee's 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.

All leaders have a role in supporting the PDR vision statement. Regulatory Leaders will:

Closely partner with the PDR Community and relevant stakeholders to build an agile network of empowered individuals.
Foster an environment of trust where individuals can openly share thoughts, ideas, and feedback with each other, and team/community impact discussions are essential.
Actively enable people to take ownership of their professional and personal development.
Role model the shared sense of purpose across PDR.
Openly share successes and failures to encourage learning.
Lead with a creative mindset and according to VACC (Visionary, Architect, Coach, Catalyst) principles.
Build an environment in which all community members can thrive.

Purpose

Together with the Portfolio Data and Content Lead, and in collaboration with the Portfolio Team co-leads, supports the delivery of the regulatory portfolio according to enterprise and PDR priorities:

Has oversight of the regulatory strategy, risk mitigation, execution, and HA interactions at the entire portfolio level.
Contextualizes internal and external regulatory developments to ensure that PDR skill sets, capabilities, investment strategies, relationships, and portfolio priorities are adequate to deliver the evolving portfolio, in line with the PDR Moonshots and True North.
Acts as a senior advisor and key stakeholder to Portfolio Team Co-Leads, who are accountable and responsible for setting and executing the regulatory and content strategy for a portfolio of products.

Job Expectations and Key Accountabilities:

This individual is viewed as a scientific regulatory expert and strategic thought leader, who can balance moving forward regulatory strategies for innovative solutions with the need to maintain our license to operate.
They will be a scientific regulatory expert and key influencer at internal Roche leadership teams, strategic enterprise initiatives, and governance bodies.
Identifies and interprets regulatory trends to build enterprise insights so that the organization can assess and adjust if necessary.
Accountable to input into the prioritization of deliverables as defined by the PDR One Enabling team and Area 2 teams and ensures prioritized work packages are understood by the portfolio teams.
Ensures Portfolio Team Leads and portfolio team members have the necessary overall business context and direction to be empowered for creating and executing strategy and HA interactions for products within the portfolio.
Brings a holistic portfolio overview to the Portfolio Team Leads Network, sharing knowledge, insights, and prioritization with the Portfolio Team co-leads to ensure clear understanding and alignment on the priorities set by the PDR One Enabling team and Area 2 decision-making.
Responsible for establishing ways of working and effectiveness of the Portfolio Teams, as well as ensuring the necessary expertise and resources are available to deliver the work and foster growth and development of the team.
Supports talent flow within, into, and out of the Portfolio Teams.
Builds an implementable and robust succession plan for future Portfolio Strategy Leads.
Acts as an advisor/consultant to any member of PDR or the wider organization.
Builds partnerships with senior key stakeholders from other functions to ensure the strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resources.
Collaborates with and influences industry associations and Health Authorities on key portfolio and regulatory policy matters.
May have direct reports.
May dedicate a percentage of their time to the Chapter, Squads, PDR projects, and/or enterprise initiatives.

Job Experience and Knowledge:

Demonstrated leadership in drug development, global regulatory strategy, and execution for a variety of products.
Experienced in managing and interacting with internal and external stakeholders.
Experienced in leading a high-performing team.
15 years of relevant experience, including a minimum of 12 years supporting cross-functional teams in a scientific environment.
Regulatory and drug development experience across multiple therapeutic areas (Oncology, Neurology, Ophthalmology, Cardiovascular Renal Metabolic, Immunology).
Knowledge of manufacturing regulatory as well as device regulations, with proven ability to influence and navigate the broader regulatory strategy behind development strategies.
Proven track record navigating highly complex projects as well as corporate-critical activities enabling business continuity.
Trusted enterprise leader who can lead initiatives on behalf of the Corporate Executive Committed, Pharma Leadership Team, Research & Early Development organizations in Roche Group (REDs), and Pharma Development Leadership Team.
External cross-stakeholder engagement (e.g., working groups, peer-reviewed publications, presentations at meetings) to advance innovation in regulatory science.

Who we are

A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advancing 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.

Let’s build a healthier future, together.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche's largest sites.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave, and 10 weeks of gender-independent partnership leave. Our employees also benefit from multiple services on-site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

Roche is an Equal Opportunity Employer.

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