掲載期間:20/11/18~21/05/17 求人管理No.015994

外資動物薬メーカー

Director Product Development & Regulatory Affairs

  • 年間休日120日以上
  • 転勤なし
  • 英語を活かす
  • 30代

募集要項

PDRAチームが成功するように動機付け、奨励し、組織内での個人的な成長をするためにチームメンバーを指導

仕事内容

Lead the PDRA organization to ensure timely approval and maintenance of biological and pharmaceutical veterinary products in Japan in compliance with the general pharmaceutical guidelines and with local laws.
Ensure that the PDRA team develops local regulatory strategies to minimize time to market in Japan, and expedites product development by leveraging global data.
Drive execution of project plans by the PDRA team according to agreed product profiles, budgets and schedules.
Provide regular updates to management and stakeholders to discuss progress and obstacles in the project portfolio.
Liaise with Sales BU in the identification of market potential/requirements for new vaccines, vaccine improvements and pharmaceutical products
Oversee the PDRA team’s collaborations with Contract Research Organizations (CROs). Ensure contract management and quality oversight of CROs.
Ensure compliance of organizational structures, internal processes, operational activities & reporting including national and overseas pharmacovigilance requirements in line with the respective pharmaceutical law guidelines
Oversee the scientific quality of work within the unit to maintain and enhance reputation for excellence
Provide advice on research issues, problems and trends having significant impact on division’s achievement of short and long-term goals
Optimize the performance of PDRA colleagues by coaching, motivating, training and evaluating them properly in line with global and local development program, including setting and reviewing individual yearly objectives and development plans

BACKGROUND REQUIREMENTS

Leadership Standards applicable to the role include:

Make Rapid, Disciplined Decisions - Make timely decisions at the right level with the right data, and support them once made.
Build Talent - Build diverse talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.
Act with Courage & Candor - Speak openly, honestly and with conviction: have the courage to take appropriate risks and make difficult decisions.
Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.
Foster Collaboration - Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the new .
Focus on Customers & Animal Health outcomes for the benefit of all stakeholders - Focus the entire organization on delivering value for customers, including the greater community by understanding and meeting their needs.
Drive Results - Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.

応募条件
【必須事項】
・Minimum 7 years of relevant experience in a regulated industry, preferably healthcare, most preferably in the field of veterinary vaccines or pharmaceuticals.
・Knowledge of Japanese Regulatory System
・Experience leading teams and developing/coaching people to maximize people/team capability.
・Working in a matrix environment with multiple stakeholders at local and global levels.
・Experience in planning and drafting budgets for approval.

スキル:
・Language - Japanese (fluent), English (professional level - verbal and writing)
・Highly developed skills in negotiating, influencing, leadership and staff motivation.
・Excellent communication and organizational skills.
・Ability to work well with other departments in a multicultural team setting and matrix organization
・Familiarity with animal diseases and animal husbandry techniques and ability to understand our product users including farmers and veterinarians.
・Ability to make sound decisions on a day to day basis concerning product development and regulatory affairs.
Knowledge of Microsoft Office
【歓迎経験】
獣医または生物科学または動物科学の博士号が望ましい。
【免許・資格】
【勤務開始日】
応相談
学歴
大学院博士以上
雇用形態
正社員
試用期間
3ヶ月

勤務地
【住所】 東京
転勤の有無
転勤なし
勤務時間
9:00~17:30
勤務開始日
応相談
休日休暇
夏季特別休暇(5日間)、育児休暇、介護休暇、看護休暇、ボランティア休暇
年収・給与
経験により応相談
諸手当
営業日当、住宅手当、通勤交通費
昇給
年1回
賞与
年2回(9月と3月)
採用人数
1名 
待遇・福利厚生
【待遇】
退職金制度、確定拠出年金制度、定期健康診断・生活習慣病検診・インフルエンザ予防接種費用補助、リロクラブ(福利厚生クラブ)加入、永年勤続表彰、社員紹介プログラム、転勤者借上社宅、単身赴任手当他
【福利厚生】
選考プロセス
1)書類選考
2)一次面接
3)最終面接

外資動物薬メーカー

Director Product Development & Regulatory Affairs

  • 年間休日120日以上
  • 転勤なし
  • 英語を活かす
  • 30代

この企業が募集している
他の求人

外資動物薬メーカー

コンパニオンアニマル向…

仕事内容:
担当地域において自社動物薬の使用・販売…
年収・給与:
500万円~
勤務地:
全国

新着外資動物薬メーカー

テクニカルサービス・マ…

仕事内容:
・担当地域のターゲット顧客に対して自ら…
年収・給与:
750万円~
勤務地:
東京

外資動物薬メーカー

Director PD…

仕事内容:
当社の製品開発および規制活動の全体的な…
年収・給与:
1000万円~
勤務地:
東京