Regulatory Affairs Associate

Responsibilities

• Support global regulatory lifecycle management activities across EU, US, and international markets
• Contribute to regulatory strategy development for global and regional submissions
• Prepare, coordinate, and deliver regulatory submission packages (Modules 1-5)
• Manage post-approval changes, variation submissions, and follow-up activities
• Handle Health Authority queries and ensure timely responses
• Provide submission management support including planning, coordination, and timeline tracking
• Maintain accurate records in Regulatory Information Management (RIM) systems
• Support safety-related regulatory activities such as aggregate reports and urgent safety updates
• Assist with audit, compliance, and inspection readiness activities
• Desired Skills & Experience
• Strong knowledge of EU & US regulatory procedures and post-approval requirements
• Experience in global submission management and lifecycle maintenance
• Understanding of regulatory documentation and compliance standards
• Strong coordination and stakeholder management skills.
• 2 to 4 years of relevant experience
• Educational Qualification
• B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy

Benefits

Additional Information

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. An Associate must have a knowledge of the organization's basic consulting models and methodologies as well as basic knowledge of what services PC provides. An Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. An Associate, under the general direction of a Project Lead and/or Technical SME, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. The guidance of more senior staff may be needed to accomplish more complex tasks. An Associate may act in a client facing role with clear guidance and support from line management.

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