Regulatory Affairs Associate Director：製薬企業

求人詳細

• Serving as a contact point for the company, coordinates for pharmaceutical affairs matters on product development between internal concerned departments and regulatory authority.
• Performs pharmaceutical regulatory affairs tasks for obtaining pharmaceutical product approval.
• Prepares various pharmaceutical regulatory affairs documents in a timely and appropriate manner according to the product development plan.
• Manages pharmaceutical regulatory affairs schedules for product development plan.
• Working with internal concerned departments, prepares appendices attached to pharmaceutical regulatory affairs documents to be submitted to regulatory authority and submits them.
• Negotiates with subcontractors and external parties about pharmaceutical affairs issues as needed.
• Working collaboratively with other departments, reviews the documents (minutes, examination report, etc.) created by regulatory authority, builds a consensus and confirm them with the regulatory authority and obtains the final version of the documents.
• Presents pharmaceutical affairs strategies for product development plan to the concerned departments and gains consensus from them.
• Support Director’s job

こんな方を求めています

経験・スキル

Regulatory Affairsとして承認申請の経験を有している方。(5年以上が望ましい。)

学歴

大学卒業以上

募集要項

職種

薬事、メディカルライティング

給与

年収 1,000 〜 1,700万円

賞与

有

雇用形態

正社員

雇用期間

期間の定めなし

試用期間

有り

就業時間

08:45～17:30

休日休暇

日曜日,土曜日,祝日

保険

健康保険,厚生年金保険,介護保険,雇用保険

受動喫煙防止措置

敷地内禁煙

特長

外資系企業, 土日祝休み, 完全週休2日制, フレックスタイム制, 語学力を活かす

業種

医療機器・医療品関連

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