Title: Global Regulatory Affairs Lead Department: Regulatory Affairs Regional coverage: US and Europe

Role Objectives:

• Responsible for planning and implementing the regulatory strategy for an investigational new drug with the aim to secure an NDA and MAA approval
• Responsible for planning, executing, and coordinating all regulatory activities specifically the pre-NDA meetings with the USFDA and the EMA Scientific Advice discussions
• Manages the end-to-end process of creating the NDA and MAA including coordination with various internal departments as well as the HA and providing guidance and insights through the same
• Experience in regulatory management systems, eCTD and other tracking systems will be a plus

Job Description:

• At least 12-15 years of industry experience, with 10+ years in global regulatory affairs including regulatory strategy, planning and execution for the launch of investigational new drugs in global markets.
• Strong understanding of the regulatory framework for drug development spanning activities from quality, non-clinical development and clinical development including the approval processes especially for the US and Europe markets
• Should have the knowledge and application of regulatory guidance of the process of securing an approval for investigational drugs / biologics, delivering regulatory intelligence and insights through the process
• Leadership role during global health agency interactions for early and late-stage development programs including proposing approaches and organizing pre-NDA meetings with the US FDA, exploring opportunities to engage in Scientific Advice with the EMA in order to facilitate the dialogue and validate the application process
• Facilitate the NDA/MAA complication process by planning and coordination across various departments involved and provide regulatory insights through the submission process
• Serve as a single point of contact for internal and external stakeholders involved in the NDA/MAA process as well as the Health Authorities
• As a regulatory lead, participate in cross functional and product development discussions
• Keep updated on the latest regulatory guideline changes which might have an impact in the submission process
• Work within a controlled, matrix environment governed by applicable SOPs and procedures

Education:

Masters in life sciences domain (e.g., Pharmacist by qualification) or hold a PhD in health sciences or pharmaceutical sciences