Senior Regulatory Affairs Specialist

Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.[WORKING CONDITIONS]Type of Contract : PermanentWorking Hour : Mon - Fri (Work from home - twice a week)Legal Entity : ZP THERAPEUTICS KOREALocation : Head Office[OVERVIEW]The Sr. Regulatory Affairs Specialist is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements in Korea[ROLES AND RESPONSIBILITIES]Maintains the product license by applying RA activities and ensures compliance with local law, regulations, guidelines by monitoring and comply with internal standard operating proceduresServes as a liaison between regulatory bodies and operating divisions of the companyPrepares and submits applications and reports to applicable regulatory agenciesResponds to requests for information from regulatory bodiesInvolved in Regional RA projects and respond in timely manner on queries based on Local regulationsMonitors regulatory affairs and the effect changes will have on company operationsDevelops and maintains professional relationships in federal, state, and local regulatory agenciesManage independently all RA works to support commercial business success and compliance to local regulationsCommunicate with all stakeholders on regulation plan and strategies and propose best resolution at the regulatory perspective to minimize any commercial impact if any urgent situationSupport for reporting adverse eventsPerforms other related duties as assigned[QUALIFICATIONS]Education : Bachelor’s degree major in Biochemistry, Pharmacy and/or Biological or Life science area at leastLanguage : English business levelExperience : Over 7 years-experience in Regulatory affairs for pharmaceutical products. MNC working experience over 3 years[COMPETENCIES]Good command of spoken and written EnglishProficient communication skills with internal team, external partner and Health Authority (MFDS) on matters to be negotiated if necessary.Passion for new business development and willingness on overcoming challengesExtensive knowledge of applicable government regulations.Ability to inform and educate managers and department heads on regulations and policies that require compliance.Excellent analytical, problem-solving, and strategic planning skillsProficient with MS office Suite and HangulGood team player[WHY JOIN ZUELLIG PHARMA]We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.Our Total Rewards program is designed to support your overall well-being in every aspect.