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  4. Senior Regulatory Affairs Manager

投稿日:2024/02/09

アボット ダイアグノスティクス メディカル株式会社 ◆48年間連続で株式配当増加の外資系トップ企業◆

Senior Regulatory Affairs Manager

ポジション情報

職種 薬事申請
雇用形態 正社員(期間の定め無し)
勤務地 千葉県
給与
給与(詳細) 年収は現職給与との相談となります
職務内容 The Regulatory Affairs Manager provides a support role to the ID Business Unit Manufacturing Site and key project activities. The Regulatory Affairs Manager reports to the Director Regulatory Affairs (manufacturing sites), ID. The role is based in Chiba, Japan.

This position applies regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs as a legal manufacturing site. This site will act as the legal manufacturing site for products manufactured in Japan. For some product/country couples, this role will be an internal supplier to an EU based LM.

○ Develop and implement regulatory strategies that appropriately assess regulatory impact and ensure earliest possible introduction of product(s) or post-market change management activities into global markets.
○ Oversee processes involved with obtaining and maintaining product release authorization and release of product to specified geographies.
○ Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.
○ Provide technical leadership for site certifications and quality management system audits.
○ Coordinates with cross functional teams including but not limited to: IVDR teams, EU Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to product release.
○ Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
○ Provides input and comment on regulations and standards which may affect division products
○ Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.
○ Apply specialized knowledge to coordinate day-to-day work.
○ Collaborate with cross-functional global teams
○ Analyze information to select appropriate options from defined alternatives.
○ Apply experience and judgment to make decisions or resolve issues within defined options or standard protocols.
○ Carries out duties in compliance with established business policies.
○ Accountable for budgets, schedules, and ensuring compliance to divisional and corporate policies as required.
○ Develop and maintain strong and effective relations with internal/external personnel.
○ Other duties as assigned, according to the changing needs of the business.
○ Independently gather resources and information needed to complete projects.
応募資格 【BASIC QUALIFICATIONS】
○ Minimum of a Bachelor’s Degree (BA/BS) from an accredited University
○ Minimum of 6 years of experience in a GMP / Biotech / Pharma / Medical Device/ IVD/ Regulated Industry.

【PREFERRED QUALIFICATIONS AND COMPETENCIES】
○ Strong written and verbal communication skills
○ Demonstrated success in the GMP / Biotech / Pharma / Medical Device/ IVD / Regulated Industry. IVD experience preferred
○ Ability to adapt quickly and effectively to shifting priorities.
○ Very strong attention to detail
○ Must be coachable and must follow written and verbal direction
○ Must be able to productively generate quality documentation to meet Program timelines
○ Flexible scheduling (if needed and advance notice is given)
○ Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint
○ General knowledge of Quality/Regulatory requirements in a medical device/ pharma/ biotech industry
○ Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment
勤務条件 〇保険:健康保険、厚生年金、雇用保険、労災
〇待遇:財形貯蓄、退職金制度、社員持株会など
〇諸手当:通勤手当、住宅手当、寮社宅、家族手当、時間外手当(役職等により)

企業情報

募集企業 アボット ダイアグノスティクス メディカル株式会社
資本金 3億円
従業員数 連結約2300名(2021年3月末時点)
企業の特徴 医薬品、医薬品原料、医薬部外品及び研究用試薬の研究、開発、製造、輸出入及び販売。
同社は、1991年にアメリカのマサチューセッツ州にて設立された、迅速なポイントオブケア診断テストの製造、販売のパイオニアです。
設立以来、心臓関連、感染症などの検査商品を、世界中の医療専門家と患者に提供してきました。
2017年10月に米国に本社を持つ医療機器メーカーの最大手企業に買収され、新たな会社としてスタートしており、現在では、COVID-19(新型コロナウイルス感染症)の抗体検査試薬やPCR検査キット、またインフルエンザなどの迅速検査キットなどの販売も行っております。
Abbott社は、心臓を中心とした脳神経外科、外科などの医療機器、医薬品、各種検査機器の販売を世界150か国以上で販売している大企業で、増収増益48年続けており、安定した経営基盤を持っております。
また、職場環境を育む努力が高く評価され、『Fortune』誌の「世界で最も賞賛される企業」にも1984年以来毎年選ばれております。

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