Regulatory Affairs manager

求人詳細

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

■Roles and Responsibilities
- Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
●Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
●A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
●Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
●Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

こんな方を求めています

経験・スキル

This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).

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 750 〜 1,100万円

賞与

YES／有り

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～17:30

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

特長

女性活躍中, 外資系企業, フレックスタイム制, 年間休日120日以上, 完全週休2日制, 土日祝休み

業種

医療機器・医療品関連

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