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大阪府の臨床開発・薬事の求人69件応募資格・募集要項・仕事内容を見る
Reg Affairs Mgr
- 給与
- 記載なし
- 勤務地
- 大阪府
- 休日
- 記載なし
- 雇用形態
- 記載なし
どんな仕事かAIによる生成
The Reg Affairs Mgr works independently as an individual contributor and may lead regulatory teams on complex projects, prepare and review regulatory or technical documents, and manage project budgets. The role also involves client and regulatory agency interactions, regulatory strategy and marketing authorization transfer activities, and may include guidance and training for junior colleagues.
この求人に応募
応募資格
必須
- Bachelor's Degree Degree in Lifescience or related discipline Req Or
- Master's Degree Degree in Lifescience or related discipline
- At least 8 years relevant experience
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
- Possesses a specific regulatory or technical expertise. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner;
- Expert in planning and delivering work on time keeping quality parameter in mind;
- Knowledge of regulatory procedures in appropriate region – particularly marketing authorization transfers and relevant cross-functional dependencies;
- Good working knowledge of regional regulatory intelligence;
- Ability to work closely with client regional heads to determine the MAT, Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable;
- Good understanding of pharmacovigilance activities relevant to transfer of marketing authorization;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;
- Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable;
- Ability to work on several projects, with direction from senior staff as appropriate;
- Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
- Ability to make decisions on discrete tasks under senior supervision;
- Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
- Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, budgets for MATs, Publishing projects;
- Project leadership experience;
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
- Ability to adapt quickly to a rapidly changing environment;
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
募集要項最終確認 10/23
- 職種
- 臨床開発・薬事
- 雇用形態
- 記載なし
- 役職
- Reg Affairs Mgr
- 給与
- 記載なし
- 勤務地
- 大阪府Osaka
- 働き方
- 記載なし
- 経験年数
- 8年以上
- 学歴
- 大学院修了以上
- 掲載日
- 2026/10/20 21:11（4日前）
- 最終確認
- 2026/10/23 13:04（1日前）
仕事内容
業務内容
- Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate;
- Competently writes regulatory and/or technical documents with minimal review by senior staff;
- Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues;
- Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate;
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
- May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff;
- May write new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
- May be involved in a Regulatory and/or IQVIA Initiative;
- Performs other tasks or assignments, as delegated by Regulatory management;
- May manage meetings with Regulatory Agencies;
- May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations;
- May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;
- Performs other duties, as business needs require;
この求人は、IQVIAソリューションズ ジャパン合同会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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募集元の採用ページから応募できます
応募はIQVIAソリューションズ ジャパン合同会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。
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