Regulatory Program Management Specialist - Program Management

F. Hoffmann-La Roche Gruppe; Digswell; Hybrid; GBP 80,000 - 100,000; Full time

Job summary

A leading global healthcare company is seeking a Regulatory Program Management Specialist. This role involves contributing to regulatory strategies and coordinating submissions to health authorities. Candidates should have a degree in Life Sciences and relevant industry experience. The position offers a hybrid work structure, with most days requiring on-site attendance. Join a team where every voice matters and help advance science for a healthier future.

Qualifications

• Proven relevant experience in the pharmaceutical/biotechnology industry.
• Working knowledge of global drug development processes.
• Effective collaboration in cross-functional environments.

Responsibilities

• Contribute to regulatory strategies for product licenses.
• Support regulatory intelligence gathering for applications.
• Coordinate submissions to health authorities for approvals.

Skills

Project delivery and leadership

Strong computer skills

Interpersonal abilities

Attention to detail

Fluency in English

Education

Degree in Life Sciences or equivalent

Tools

G Suite

Microsoft Office Suite

Adobe Acrobat

Veeva Vault

Job description

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

A 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.

Pharma Development Regulatory (PDR) is a global, flexible, bold, and distinctive regulatory organization. We make decisions quickly and strategically as the environment & landscape evolve. We innovate. Within the PDR Program Management Chapter, we are responsible for delivering global regulatory strategy and end-to-end execution of clinical projects in the Roche pipeline and portfolio, in order to develop and maintain Roche product licenses to meet the needs of our patients. We deliver the regulatory components of clinical development and registration programs for products both pre- and post-licensing. We do this by developing innovative and effective global regulatory strategies, assessments and plans, and support documentation in collaboration with our regional regulatory affairs counterparts, cross functional product teams, corporate partners and global health authorities, based on current regulatory knowledge and expertise.

As a Regulatory Program Management Specialist in the Program Management Chapter, you will support global Health Authority interactions and procedures, represent PDR on cross-functional project teams and ensure the consistent and safe use of our medicines through high-quality labels. Additionally, you understand how data and information contribute to the quality of our submissions.

The Opportunity

• Contribute to the development and implementation of regulatory strategies and risk mitigations to facilitate the development, approval and life cycle management of Roche product licenses
• Participate in discussions and contribute to interpreting the needs of worldwide evolving pharmaceutical regulations
• Support gathering of regulatory intelligence necessary to generate, interpret and present insights that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing
• Coordinate the timely submission of applications to/interactions with health authorities for approval of clinical trials, new products and line extensions
• Coordinate successful issue management

Who you are

• Degree in Life Sciences or equivalent, with proven relevant experience in the pharmaceutical/biotechnology industry, including independent project delivery and leadership.
• Strong computer skills across G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault.
• Working knowledge of regional/global drug development processes, regulations, and guidelines (GxP, GCP, ICH) and an understanding of GVP and GCP principles including data integrity.
• Strong interpersonal abilities, effective collaboration in cross-functional and matrix-based environments, and fluency in English (verbal and written).
• Ability to work under minimal supervision, detail-oriented with excellent administrative and project planning skills, dynamic, curious, adaptable, and driven by a growth mindset.

Our team follows a hybrid work structure (majority of days on-site is required)

Relocation benefits are not available for this job posting.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.