Regulatory Affairs

職種

• 医療機器薬事/法規対応

• 医薬品薬事/法規対応

仕事内容

薬事 Regulatory PM Associate (RegPMa) provide extensive support to develop client’s products, multiple projects at a time, regularly interact and communicate with client staff (including senior client staff) as the client’s main point of contact, and must work to high standards with minimal supervision. RegPMa work with a variety of global clients, generally virtual or small to mid-sized companies, across all asset types (CDx, IVD, MD, drug, biologic, cell/gene therapy), and across all therapeutic areas. Essential Job Duties: Manage multi-functional regulatory projects. Participate in cross-functional initiatives. Involvement in leading proposal and bid defense efforts for regulatory projects where more than one Regulatory function is included. Lead Product Development Team, which is a multidisciplinary team, across the entire enterprise for the client’s relationship, localization, the drug development goal, etc. Contribute to GRA materials for proposal templates, Account Executive training, and GRA capabilities content. Identify, promote and implement best practices for GRA driving for sustainable competitive advantage. Work with CTMO and GRA Leadership to: Recommend areas of improvement across clients to enhance operational performance, Lead improvement processes and ensure implementation throughout the organization. Participate in and/or lead business development activities to increase business for regulatory services and enterprise molecule development work. Perform other duties as assigned by GRA Leadership.

求める能力・経験

Minimum Required: Degree in Life Sciences or equivalent Experience in the Pharmaceutical / IVD /MD industry in Regulatory Affairs or Drug Development, Medical device development, Diagnostic drug development Business level of English and Japanese(including speaking)

語学

英語でネイティブレベルで会話可能、英語でビジネス会話が可能

雇用形態

給与

700万円〜1,000万円

勤務時間

休日・休暇

社会保険

備考

配属先

転勤

住所

東京都中央区

制度

その他

制度備考