Regulatory Submission Manager (Immediate start)Collaborate with Global Regulatory Team Leads, and submission teams to ensure timely, high-quality regulatory submissions that comply with global guidelines and company SOPs. Provide mentorship and training to team members, fostering excellence and first-time-right submissions.Responsibilities/Experience Deliver marketing, investigational, and lifecycle maintenance submissions in compliance with regulatory timelines and standards.In-depth knowledge of the pharmaceutical industry, regulatory affairs, and drug development (pre-IND through Phases I-IV).Proven ability to interpret regulations and align on complex strategies. Lead submission teams for renewals, label harmonization, PBRERs, and other regulatory activities.Experience managing projects and working within matrix environments.Develop delivery strategies and accelerate timelines through scenario planning for multiple regulatory approaches.Liaise with regulatory agencies to address queries and resolve submission-related issues.Act as the POC, maintaining workplans and tracking milestones aligned with product development phases.Support teams with expert advice on submission processes and market-specific requirements, while mentoring and coaching team members.Process Optimization: Lead or contribute to initiatives aimed at improving workflows and ensuring regulatory compliance.Identify and address risks, escalating issues when needed to ensure seamless progress and transparency.Lead multidisciplinary discussions on submission strategies, timelines, and resource management. Immediate start!!
Job Title
Apsida Life Science | Regulatory Affairs Manager