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** **People Lead - Regulatory Capabilities** **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. The Pharma Development Regulatory (PDR) Innovation and Sustainment Chapter is responsible for developing and sustaining business capabilities within PDR. We focus on fostering innovation, ensuring operational readiness, and implementing continuous improvements. Our team anticipates regulatory landscape changes and evaluates future business needs to achieve PDR's moonshots and Pharma vision. We maintain compliant, efficient regulatory processes, systems, and tools to meet patient and business needs, and understand the impact of data and information on submission quality. As a member of this chapter, you will leverage talent across PDR to drive innovation, lead continuous improvement, and oversee regulations and internal standards. Your responsibilities include assessing processes, tools, and technology to achieve our business goals, collaborating enterprise-wide to ensure compliance, and partnering with quality organizations across Product Development (PD), affiliates, Pharma, and Roche. **The Opportunity:** **Key Responsibilities & Expertise:** **1. Regulatory Expertise & Operational Excellence** + Global Regulatory Lifecycle Management: Deep expertise in leading the compilation and submission of NDA, ANDA, BLA, and MAA filings. You must have a proven track record of managing original submissions and post-approval changes across major markets (FDA, EMA, etc.). + eCTD & Content Strategy: Advanced knowledge of eCTD format requirements and a high-level mastery of Quality Overall Summaries (QOS) and CMC sections to ensure dossiers are "deficiency-free." + Regulatory Tech-Innovation: Proven experience in advocating for and implementing Automation and Innovation initiatives including AI-enabled solutions. You should be comfortable partnering with IT/Tech teams to move toward data-driven, tech-enabled transformation initiatives for the regulatory landscape. + Compliance & Risk: Demonstrated ability to apply GVP/GCP compliance and data integrity standards using a balanced, risk-based approach rather than a purely "check-box" mentality. + Proven track record in preparing for and addressing audit findings, including oversight of Corrective and Preventive Actions (CAPA) and development of remediation strategies. **2. Strategic Thoughtpartner** + Ability to partner with leads from various PD functions to set and execute the regulatory strategy for a broad portfolio of assets, ensuring alignment with global health authority interactions. + Expert administrative and project planning skills, with the ability to manage resource allocation, project prioritization, and high-pressure deadlines under minimal supervision. + Act as a strategic consultant to the PDR Community, providing high-quality analytics, insights and recommendations that influence the broader Product Development (PD) division. + A self-starter with an innovative mindset who doesn't just identify regulatory hurdles but actively solves business problems to support. **3. People Leader** + Ability to operate within the Roche framework as a Visionary, Architect, Catalyst, and Coach (VACC Framework). You will be required to spend roughly 30% of your time purely on people development. + Natural passion for people leadership with a track record of coaching and mentoring team members. You focus on building trusting relationships, removing barriers, and fostering an agile, empowered team culture, ensuring a pipeline of future regulatory leaders within the affiliate/region. + Highly skilled at building trusting relationships with various internal and external stakeholders, and ability to collaborate across various teams. **Who you are:** + You hold a bachelor's degree in Life Sciences, Pharma, Clinical Research or equivalent and 7+ years of experience in the pharmaceutical/biotechnology industry, specifically within Regulatory Affairs and Product Development. Preferably, you have a Master's degree. + Certification or PG Diploma in Regulatory affairs course is highly recommended. + Proven expertise in managing the eCTD lifecycle and a deep understanding of CMC strategy for original submissions (NDA/BLA/MAA) and post-approval variations. + Solid understanding of drug development and GxP/GCP/ICH guidelines, combined with high proficiency in digital tools (Veeva Vault, eCTD software, gSuite) to drive automation and process improvements. + Excellent interpersonal skills with the ability to navigate complex matrix environments. You are a thought partner who can influence senior stakeholders and collaborate with Allied teams (QA, Medical & Regulatory Writing, etc.). + A highly motivated, detail-oriented professional who is learning-oriented and committed to delivering deficiency-free regulatory documentation in a fast-paced environment. Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Hyderabad. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. **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.**