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 PositionRegulatory Data & Content Specialist - Disclosures
Roche India – Roche Services & Solutions
Chennai/ 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 PD, affiliates, Pharma, and Roche.
Your Opportunity:
Be the subject matter expert on product development lifecycle, especially in regulatory functions
Develop a deep understanding of clinical & regulatory pathways and product development in the pharmaceutical industry
Assist in posting organizational clinical trial protocols and results on public trial registration websites (ClinicalTrials.gov, EU results registry)
Identify studies required for registry and results postings and ensure PDR management and staff are aware of timelines and requirements
Liaise with project teams and affiliates to ensure understanding of regulatory disclosure responsibilities.
Submit protocol documents for registry entries and quality control checks for consistency
Work with cross-functional team members to gather necessary data and approvals for registry and results postings
Monitor workflows for timely completion of registry and results entries, ensuring uploads are done on time
Track and ensure timely responses to correspondence with cross-functional teams and departments
Who you are:
You hold a bachelor's degree Bachelor’s or Master’s Degree or Pharm D in Life Sciences, Pharmacy, Clinical Research or equivalent with 4+ years of relevant experience in the pharmaceutical/ biotechnology industry, specifically in regulatory affairs and regulatory writing
Certification in Regulatory Affairs course is good to have (e.g. PG diploma in Clinical research or regulatory affairs)
Strong computer skills (Microsoft Office Suite, gSuite, Adobe Acrobat)
Solid understanding of drug development, and familiarity with regulations and guidelines (e.g. GxP, GCP, ICH) and clinical trial disclosure
First exposure to regulatory affairs or product development functions
Strong interpersonal and communication skills, effective team member in cross-functional and matrix-based environments, with a strong sense of urgency.
Ability to work under minimal supervision, excellent administrative and project planning skills, detail-oriented, ability to meet deadlines and work under challenging timelines. Fluency in English (verbal and written) is required.
Self-starter with innovative mindset and passionate about solving complex problems
Highly motivated, learning oriented and quality-focused individuals would be preferred
Partner-service mentality, collaborative attitude & can-do attitude
Ability to work in a fast-paced and changing environment, ability to prioritize tasks
Experience in regulatory affairs and regulatory writing is highly recommended
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.
Top Skills
Roche Chennai, Tamil Nadu, IND Office
48, 50, Prakasam St, Gangai Karai Puram, T. Nagar, Chennai, Tamil Nadu, India, 600017
