Regulatory Affairs Associate Manager

7 hours ago

Taipei, Taiwan The businesses of Merck KGaA, Darmstadt, Germany Full time NT$120,000 - NT$180,000 per year

與我們攜手施展你的超能力  

準備好接受挑戰,探索更多可能性嗎? 我們跟你一樣希望精益求精,持續突破 我們全球的夥伴熱衷於科技創新,透過我們醫藥保健、生命科學和電子科技業務的解決方案豐富人們的生活。讓我們一起環抱著熱情和夢想關懷我們的員工、客戶、病患和這個世界。這就是我們不斷尋找具備好奇心的新血加入的原因,與我們一起大膽想像各種可能。

在醫藥健康領域,我們團結一致,齊心為病患,幫助孕育、改善和延長生命。這是我們的目標,也是我們每天不懈努力的原因。默克在腫瘤、神經變性疾病和輔助生殖等領域不斷開發創新藥物、智慧設備與創新科技。我們的團隊遍佈全球六大洲,在共同的理念與好奇心驅動下,我們全力以赴地為處於生命各個階段的患者提供擁抱新生活的機會。加入我們,成為這個多元、包容、靈活工作文化的一份子,並獲得在全球範圍內的個人職業發展機會。

Job Description

Be actively involved in the development and life-cycle management of medicinal products thereby contributing to appropriateness of the drug development path as well as to compliance with applicable pharmaceutical legislation / regulation. And assist the local regulatory lead in preparation and execution of regulatory strategies and to manage the submission and approval of applications for marketing applications or other related regulatory submissions.


Your Role



• Providing support to regulatory related timely submissions and registration maintenance, other activities assigned as appropriate.

• For projects assigned, develop and provide input to the development of sound regulatory strategies and properly execute them.

• Elaborates risk mitigation plans that support the company's portfolio. Critically review regulatory submissions for portfolio and countries assigned.

• Act as functional expert on local/regional/global project teams for projects and countries assigned, interpreting issues and provide
strategic input to project team on the application of local regulations, review processes and submission requirements.

• Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.

• Provide input to critical submission documents and agency responses throughout the product lifecycle to ensure that they support local requirements of all countries assigned.

• Develop and manages optimal labeling for all products, countries assigned throughout the product lifecycle in close alignment global labeling group and meeting corporate labeling standards.

• Ensure review and release of promotional material according to local regulations and corporate policies and procedures for portfolio and countries under responsibility.

• Establish and maintain excellent working relationships with review staff of local health authority where applicable, and other local regulatory agencies, as required



Who You Are



• Minimum of 5 years' relevant work experience in RA field

• Experience with assisting in the preparation and writing regulatory documentation to support agency interactions

• Demonstrated knowledge in NDA / CTD requirements

• Bachelor's Degree in Pharmacy preferred or other Science degree

• Good interpersonal skills

• High Attention to detail

• Ability to work in teams

• Strong organizational and planning skills

• Advanced skills for standard MS office

我們來自不同背景、視角與生活經歷,因對世界的好奇心而聚集在一起。我們深信,多元能夠催生卓越與創新,並持續強化我們在科學與技術領域的領導地位。我們致力於為每一個人創造機會,讓大家能依自己的節奏發展與成長。加入我們,一同打造一個充滿包容與歸屬感的文化,影響數百萬人的生活,攜手推動人類的進步

立即申請,成為這個致力於激發探索精神、提升人類未來的團隊一員

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