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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 Manager, Regulatory Affairs
Job ID R0000043228 , IndiaA Senior Manager within R&A provides leadership and direction to consultants, senior consultants and managers, actively managing employee performance and development. A Senior Manager acts as a role model and provides a broad range of consulting services and may be responsible for a specific function/technical area.
Key Responsibilities
- Extensive experience in Regulatory Affairs, including expertise in EU Clinical Trials Regulation (EU CTR) and experience leading and developing teams.
- Act as the Subject Matter Expert (SME) for the EU Clinical Trials Regulation (EU CTR), providing strategic regulatory guidance and ensuring compliant implementation.
- Drive capability building within the team through coaching, mentoring, training, and knowledge-sharing initiatives.
- Contribute to organizational EU CTR-related projects, process improvements, and strategic initiatives.
- Support the development, review, and maintenance of functional Standard Operating Procedures (SOPs).
- Provide support during regulatory audits and inspections.
- Deliver regulatory consultancy and client-focused guidance, fostering strong stakeholder partnerships.
- Lead and manage a team, ensuring performance, development, and operational excellence.
Skills and Competencies
- Strong expertise in EU Clinical Trials Regulation (EU CTR) and associated regulatory requirements.
- Ability to interpret regulatory intelligence, assess impact, and translate requirements into practical processes and implementation plans.
- Solid understanding of regulatory operations, workflows, and compliance standards.
- Excellent stakeholder management and communication skills, with experience collaborating across global teams and clients.
- Strong analytical, problem-solving, decision-making, and risk mitigation capabilities in a dynamic environment.
- Demonstrated ability to work collaboratively and influence cross-functional teams in a consultative manner.
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