【非公開求人】承認申請から当局対応まで担う薬事スペシャリスト｜外資系グローバル企業｜年収800万｜東京

JOB DESCRIPTION: MAIN PURPOSE OF THE ROLEExperienced professional individual contributor that works under limited supervision.Applies subject matter knowledge in the area of Regulatory Affairs.Requires capacity to apply skills/knowledge within the context of specific needs or requirements. MAIN RESPONSIBILITIES? As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.? Interacts with regulatory agency to expedite approval of pending registration.? Serves as regulatory liaison throughout product lifecycle.? Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).? Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.? Serves as regulatory representative to marketing, research teams and regulatory agencies.? Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

大学卒業以上 医療機器・医薬品・体外診断薬いずれかの分野での薬事経験（クラス不問） または 臨床検査関連・感染症関連での臨床開発／品質管理／R＆Dの経験 業務上の英語の読み書きが可能であること

完全週休2日制（土・日）、祝祭日、夏季休暇、年末年始、年次有休休暇、母性健康管理のための休暇（産前産後休暇・育児休暇・育児時間）等、子の看護休暇、介護休暇、生理休暇、誕生日休暇