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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Regulatory Affairs Associate (Marketing Application)
Job ID R0000038906 , ArgentinaThe 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.
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