パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Senior Regulatory Affairs Associate (Marketing Application)
応募 求人ID R0000038906 ロケーション アルゼンチン共和国 仕事内容The Senior Associate will provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position.
- Lead Local Regulatory Responsible (LRR) oversees LRRs to ensure effective deicion making and mooth operations and acts as the first escalation point for LRR challenges.
- Local Regulatory Responsible focuses on local regulatory requirements and Health Authority national engagements.
- The key interactions are with local external stakeholders e.g. Health Authorities, Local industry association(s), In Market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA Regional team
Experience:
- 5+ years of (local) regulatory knowledge and experience in a regulatory authority facing role; i.e. comprehensive understanding of regional and global regulatory requirements, guidelines and processes
- Leadership experience
- In-depth expertise on local health authority management
- Project management skills and leadership skills; i.e. proven experience in managing e.g., regulatory submissions, timelines and cross-functional teams to ensure timely and successful product registrations and compliance
- Experience in managing ComOps Stakeholders: matching influencing style to stakeholders to maximise impact and effectiveness of GRA expertise, proactively identifying opportunities to influence stakeholders on business critical decisions and employing a systematic approach to influence key internal stakeholders based on business needs and objectives
- Experience in successfully dealing with rapid change
Competence:
- Fluent in local language and English, oral and written
- Relevant bachelor’s degree or equivalent secondary education e.g. natural sciences (biology, chemistry with pharmacological focus)
- Expert MS Office skills
- Excellent organizational, time management and interpersonal skills in a global environment.
- Ability to work successfully in a complex global matrix organization.
- Proven ability to work effectively both independently and in a team.
- The expertise, determination and courage to resolve or escalate issues as appropriate.
