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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.
Regulatory Affairs Consultant- Regulatory Partner Responsible
Job ID R0000041920 , IndiaRegulatory Partner Responsible (RPR) focuses on partner management and oversight of partner activities. The key interactions are local partners, In Market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA Regional team.
Main Responsibilities and Accountabilities
Strategy (execution) & (partner) management
- Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards; monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly.
- Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implement corrective actions as necessary; develop risk mitigation strategies and implement controls to minimize risks associated with partner activities. Act as point of contact for escalations and issue resolution related to partner activities.
- Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team; participating in policy activities with industry groups and trade associations.
- Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs.
- Keep internal databases up to date with local activity and ensure compliance KPIs are adequately kept on track.
- Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with Has.
- Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance.
Experience
- Ideally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry.
- Partner management experience: proven experience in managing relationships with third-party vendors.
- Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive.
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