Sr. Regulatory Affairs

该职位来源于猎聘 Purpose: To drive growth by (a) developing our business to achieve top line goals in assigned or break-in accounts, and (b) strengthening the organization’s partnership with existing and new clients Identifying appropriate targets and expand footprint among existing accounts and new accounts. Indegene is a specialized healthcare solutions company with a unique blend of life science domain expertise and technology capabilities. Headquartered in Bangalore, with offices across the world, Indegene is partner to pharma companies helping transform their commercial and medical operations. As life sciences companies embrace digital for more personalized customer engagement, Indegene enables the pharma companies by bringing together deep medical and analytics expertise and contemporary AI and Big Data technology. Responsibilities:

• Advise the Global Regulatory Team on regional considerations in developing strategy
• Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
• Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within client’s portfolio in compliance with global filing plans and local regulatory requirements.
• Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
• Leads development of regional regulatory documents and meetings in accordance with GRT strategy
• Provides regulatory direction on regional regulatory mechanisms to optimize product development
• Review regulatory dossier preparation and submission like new drug application, import license, site registration etc.
• Interacting with clients and follow up till final submission
• Identify and design training programs for team members
• To prepare team for Audit ready with updated regulatory guidelines, process and to prepare audit response report
• Conducting regular client calls for content-related discussions as well as for project status updates and delivery
• Expert in reviewing regulatory intelligence information (requirements for CTA, drug/device/cosmetic/food registration etc....) and delivers to client
• Provided valued inputs for establishment, streamlining, and improvement of project processes
• Performing RCA when required with the team and preparing CAPA
• Work with internal stakeholders for project execution and actively participate in team meetings
• Ensure high standards of regulatory compliance as per client requirement.
• Maintain knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines Desired Skill Set:
• Excellent knowledge of global regulations and hands-on experience in preparing and regulatory submission to China Health Authority (NMPA)
• 5-8 years of relevant experience
• Bachelor’s or Master’s in Life Science