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

Regulatory Affairs Business Partner

Roche India - Roche Services & Solutions

Hyderabad

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.

Mission

Roche Services & Solutions (RSS) aims at "transforming the way Roche operates.'' As a global organization of over 3,500 colleagues, we enable Roche to operate in a competitive and ever-changing business environment. We provide our partners with end-to-end business services and solutions, enabling them to focus on patient-centric activities. Embracing an OneRoche mindset, we leverage our global network located in Budapest (Hungary), Riga (Latvia), Chennai & Hyderabad (India), San José (Costa Rica), Kuala Lumpur (Malaysia), and our other sites to remain customer-centric 24/7 and co-create solutions together.

As a dedicated member of the RSS organization, this position acts as a strategic business partner to the Product Development (PD) division. You will identify opportunities, initiate new operational models within RSS, and scale them to stability to support the evolving needs of global drug development and continuous innovation.

The Opportunity

We are seeking a strategic, entrepreneurial leader to build, scale, and evolve RSS capabilities that directly support Product Development functions. Combining deep regulatory expertise with strong leadership, you will act as a vital bridge between RSS and PD. You will launch initiatives and enhance cross-functional collaboration across regulatory, medical affairs, and development functions to ensure RSS provides top-tier operational support to the PD organization.

Key Responsibilities

Regulatory & Compliance Expertise:

• Lead global regulatory lifecycle management, overseeing compilation and submission of NDA, ANDA, BLA, and MAA dossiers for major agencies (FDA, EMA) on behalf of PD partners.
• Ensure effective eCTD and content strategy, applying QOS and CMC documentation expertise to deliver high-quality, inspection-ready dossiers.
• Uphold compliance, risk management, and audit readiness, maintaining GVP/GCP standards, data integrity, and CAPA oversight.

Regulatory Writing Leadership:

• Lead and manage the regulatory writing team, overseeing the preparation, review, and delivery of high-quality clinical and regulatory documents in alignment with Product Development submission timelines and quality standards.

RSS-PD Partnership & Integration:

• Support Medical Affairs activities related to scientific communication, evidence generation, and publication planning, ensuring RSS deliverables align with PD objectives.
• Act as the RSS liaison to the broader PD ecosystem (Clinical Operations/Science, Data Science, Portfolio Strategy, Quality, and Safety) to integrate strategies and drive cohesive program execution.

Strategic Capability Building & Innovation:

• Identify emerging needs within the PD group to initiate, establish, and scale new functional capabilities, frameworks, and service offerings within RSS.
• Drive regulatory technology innovation, partnering with IT on digital tools, automation, and AI-enabled initiatives that benefit PD operations.
• Act as a trusted thought partner to PD leadership, contributing external RSS insights to development strategy, resource planning, and portfolio prioritization.

People & Stakeholder Leadership:

• Lead, mentor, and grow a high-performing team of regulatory and allied professionals, maintaining accountability for strategic hiring, continuous development, and the oversight of high-quality deliverables.
• Operate within the Roche VACC (Visionary, Architect, Catalyst, and Coach) framework to mentor RSS teams and develop future leaders.
• Build trusted partnerships across the RSS and PD divide, removing barriers to enable seamless collaboration across global, matrixed teams.
• Who You Are
• You hold a master's degree in Life Sciences, Pharma, Clinical Research, or equivalent and 10+ years of experience in the pharmaceutical, biotechnology, or healthcare industry, specifically in regulatory, drug development, or scientific communication. Preferably, you have a Master's (MBA) in Healthcare Management, Pharmaceutical Management, Strategy, or Operations.
• Capability Building: Demonstrated success in initiating, building, and scaling new operational frameworks or service offerings within complex, matrixed environments (e.g., shared services or business partner models).
• Leadership: Proven people leader with a track record of managing diverse teams and aligning multiple functions globally.
• Mindset: Strategic, entrepreneurial problem-solver with a strong interest in leveraging emerging technologies for process transformation.
• Communication: Exceptional stakeholder management skills, specifically equipped to partner with and influence senior leaders in external or supported business units.

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.

Roche is an Equal Opportunity Employer.