Sr Regulatory Professional

Job description

Job Title Senior Regulatory Professional Job Summary Shape regulatory strategies that bring life-changing diabetes therapies to patients in every corner of the world. As an Associate Regulatory Specialist, you'll be the link between science, health authorities and the millions of people who depend on our medicines with the autonomy to set direction, the expertise to influence outcomes, and the support of a global team behind you. Your new role As an Associate Regulatory Specialist in RA Diabetes, you will take ownership of regulatory submissions and interactions across major markets, acting as a subject matter expert within one or several regulatory processes. You'll work independently on most situations while shaping better practice for the team, mentoring junior colleagues and driving the regulatory strategy that supports our diabetes portfolio. Responsibilities - **Global regulatory submissions:** Develop and execute Regulatory Affairs Submission Plans in Vault RIM, prepare and publish regulatory files, and manage MAA/NDA/BLA, CTA/IND, PIP/PSP submissions, renewals, post-approval changes, pharmacovigilance documents (DSUR, PSUR, RMP), and meeting packages worldwide - **Health Authority interactions:** Plan and conduct engagements with FDA, EMA, PMDA and other authorities including preparing meeting requests, leading rehearsals and capturing minutes of formal meetings - **Core labelling:** Establish and maintain the target CCDS/CCDS and European labelling for products in development, link the Target Product Profile to commercial and market access requirements, and support US labelling and Life Cycle Management - **RA Process expertise:** Identify and develop better practice, driving improvements in regulatory documentation, methods and strategies - **RA Due Diligence:** Lead regulatory due diligence assessments to inform business decisions - **RA Clinical expertise:** Chair or contribute to Clinical Project / Clinical cross-functional groups, applying your submission experience across China, Japan, US and EU Your department In Research Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs. You will join RA Diabetes in Global Regulatory Affairs Bangalore, reporting to the Associate Director, RA Diabetes. The department works globally with Clinical Operations, Medical Science, Global Safety, Global Medical Affairs, Global Marketing/Patient Access, Legal, Quality, RA affiliates and health authorities to support product development, approvals and lifecycle management. Together, we focus on high-quality regulatory submissions, continuous process improvement and collaborative cross-functional engagement to bring safe and effective therapies to patients worldwide. Your skills qualifications We're looking for a confident regulatory professional who combines deep technical knowledge with a strategic mindset and the boldness to make risk-based decisions. To succeed in this role, you'll bring: - A PhD, Master's or Bachelor's degree in life sciences, with 79+ years of relevant Regulatory Affairs experience or equivalent knowledge gained through practical experience - Strong expertise across several regulatory affairs disciplines such as regulatory science requirements (EU, US, China, Japan), Life Cycle Management, label development, Health Authority interactions, device development, regulatory intelligence and therapeutic area knowledge - Submission experience across major markets (China, Japan, US, EU) and a track record of identifying and implementing process improvements - Broader understanding of project management, the RD value chain, pharmacovigilance, clinical pharmacology, real world evidence, digital health and patient access - Excellent written and spoken English, with strong cross-functional communication skills and the ability to operate effectively in a multicultural environment - An open, accountable and inclusive mindset goal-oriented, organised, persistent, and able to handle ambiguity, variable workloads and complex information with empathy and a collaborative spirit Experience Level Senior Level Disclaimer : This job posting & Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.