Senior Manager Regulatory Affairs

Senior Manager - Regulatory AffairsMedytox, Inc. www.medytox.comPosition SummaryThe Senior Manager Regulatory Affairs is responsible for implementing and guiding activities needed to secure and maintain Global marketing authorization, with an emphasis on recent experience in the US and Europe. This role involves extensive interaction with regulatory agencies such as the FDA, EMA, PMDA, NMPA Health Canada, and other leading regulatory agencies. The role will provide scientific advice, cross-functional support and authoring/reviewing submission documents for regulatory applications, GMP manufacturing and product maintenance. This position will work closely with Medytox Quality, Production, Clinical and Regulatory teams to ensure products and business activities are in compliance with regulatory requirements and Medytox quality standards. The ideal candidate will have extensive experience working in successful regulatory teams and a recent record leading approved US and EU BLA submissions.Key ResponsibilitiesResponsible for the successful submission of the company’s registration applications.Ensure compliance with all applicable Medytox policies and regulatory requirements.Exercise broad based risk assessment regarding quality policies and practices and implementing effective changes.Ensure customer complaints are processed effectively and in collaboration with Medytox Quality team.Understand Medytox’s vision/mission and promote it within the organization.Successfully and efficiently plan and execute activities necessary to ensure compliance with all applicable health authorities.Interface externally with auditors, partners, regulators, and others as a credible, influential, and respected company spokesperson.Understand relevant industry trends and guide leadership accordingly.Work effectively and collaboratively with all related Medytox functions.Required Skills/AbilitiesBachelor’s degree with 5+ years’ Regulatory Leadership roles, advanced degree preferred.Experience in the biologics sector, with preference given to botulinum toxin CMC experience or other successful BLA approvals in the past 5 years.Significant experience and understanding of GMP and principles of regulatory compliance. Experience working in a global, multicultural organization.Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.Ability to collaborate with onsite, hybrid and remote regulatory teams. Experience in hosting FDA, EMA and other regulatory inspections.Regulatory experience with BLAs, NDAs and PMAs would be preferred.Ability and willingness to relocate to South Korea, and travel to other locations as required.Benefits and CompensationCompetitive salary commensurate with experience.Comprehensive benefits package.4 weeks’ vacation and paid Holidays.