薬事マネージャー

Job Details

<求人タイトル>

17933 薬事マネージャー

<職務内容>

Key Accountabilities:
・Achievement of timely submissions and approvals.
・Accurate projections for regulatory approvals.
・Maintain regulatory compliance.
・Lead sub-divided team within department (if required)
・Lead cross-functional team within company (if required)
Key Tasks:
・Update RA head on approval projections in a timely manner.
・Act as the primary interface with internal stakeholders.
・Contribute in business development from the aspects of regulatory.
・Conduct preparation of regulatory submissions and responses to regulator.
・Handle regulatory inspections and preparations as required.
・Capture any regulatory changes and communicate the impact with internal stakeholders
proactively.
・Complete all deliverables on time to fulfill MAH representative responsibilities in case that
he/she is in charge.

<応募要件>

・BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, pharmacology, engineering, medical or law.
・Advanced degree or additional professional training is preferred.
・A license of Pharmacist is desirable.
・8+ year experience in Regulatory Affairs or equivalent.
・Successful submissions for medical devices, quasi drugs or RX.
・Demonstrated communication skill in international business environment.
・Regulatory experience with pharmaceuticals is desirable
・Leadership skill demonstrated in business setting.
・Hands-on submission experience.
・Analytical and problem solving skills.
・Ability to read, analyze and interpret regulations, technical documents and business numbers.
・Good oral and written communication skill demonstrated in medical business setting.
・Business English in writing and verbal.

<会社概要>

世界有数の大手ビジョンケアカンパニーです。各種コンタクトレンズの他、眼科手術用医療機器なども開発・販売しています!

就業時間: 9:00-17:30 (フレックスタイム制:コアタイム10時~15時)

<注目ポイント>

世界的にも非常に歴史の長い外資系大手コンタクトレンズメーカーのマネージャー案件です!日本はコンタクトレンズ業界において世界第2位の市場規模を誇っており、過去30年間で国内市場規模は4倍以上に拡大しています。ニーズが非常に高くまだ伸びしろのあるこの分野でのご経験は、今後のご自身のキャリアにも非常にプラスになるかと存じます!ご興味がございましたら、是非お気軽にお問い合わせください!

Job application