• Purpose of position
• - Contribute to rapid and accurate new product licensing and sales improvement through a strategic approach agreed with the Astellas global.
• - Supports product licenses to obtain, maintain and manage through continuous updates and timely sharing of domestic regulations.
• Organization Fit
• - Reports to Director, Head of Regulatory Affairs
• Essential Job Responsibilities
• - Establishes a strategic plan in conjunction with global objectives to obtain, maintain and manage domestic product licenses for Astellas products and strives to be implemented within the deadline.
• - Lead activities to set regulatory strategy for new products in partnership with internal stakeholders to maximize business opportunities for new and on-going product registration and management
• - Formulate strategies to support accelerated submissions/approvals utilizing advancements in the regulatory environment
• - Manage Astellas' new products (NDA/DMF/BLA) based on global/regional development plan as well as proficient knowledge of local regulations and regulatory requirements.
• - Ensure effective maintenance and management of product licenses (compliance/annual reports/renewals) – plan to obtain, maintain and manage and to submit relevant data to the HA in accordance with internal and external demands and environmental changes.
• - Update and share SOP related to domestic regulations and global RA – understand and update the Guideline/SOPs so that the team can apply in a timely manner to obtain/maintain/manage Product licenses. And Supports team members to understand and ute domestic regulations and Astellas SOP/Code/WPD.
• - Talent development - Coaching team members according to fair standards and feedback to maximize their capabilities and grow the performance results.
• - SOP Management - Contribute toward regional/global SOP as necessary and create and manage the Local RA SOP linked to the Global RA policy. Modify the SOP according to changes in global policies or changes in domestic licensing regulations.
• - Make sure that promotional material used to be aligning with relevant code, regulation and requirement
• - Maintain, monitor and provide input on local regulatory environment and policies, be updated on new regulations, assess implications to the business, develop and ute strategies considering regulation changes
• - Participate in industry groups to enhance Astellas’s role in driving an optimal regulatory environment
• - Lead and/or contribute to project assignments as determined by the Head of Regulatory Affairs
• Knowledge, Experience, and Abilities Require
• - Knowledge on the relevant laws, regulations and guideline in Pharmaceutical industry
• - Established career in the pharmaceutical industry in RA, Development and relevant field
• Basic understanding on pharmacology and physiology
• A mind-set of continuous improvement, innovation and be solution-focused with strong problem solving ability
• A strong sense of commercial acumen and have met department goals within specified timelines
• Effective communication with stakeholders (e.g. regulatory authorities, region HQ, global team, etc.)
• - A strong commitment to integrity and professionalism and a commitment to excellence.
• - Competent English skill
• - Leadership and coaching skills

• Preferred qualifications include:
• Bachelor degree (or higher degree) of Pharmacy or related major. (Pharmacist preferred. MS degree preferred)
• Over 8 years of relevant Regulatory Affairs expertise in the pharmaceutical industry preferred. Experience less than 8 years also can be considered.
• Experience in registration of biologics, oncology and life-saving medicines and active participation in industry working groups would be an advantage preferred

• [기본]
  ▸ 자격증 사본(해당자에 한함)
• ▸ 국가보훈대상자는 취업지원 대상자 증명서 제출
• ▸ 장애인 대상자는 장애인 증명서 제출
• [필수] ▸ 최종학교 졸업증명서 및 성적 증명서
• [필수] ▸ 이력서에 기입 된 재직(경력)증명서 전체
• [필수] ▸ 영문 CV

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