Senior Regulatory Affairs Associate

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company 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 reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides. A Senior Associate must be technically competent and continually developing the skills as defined in the key accountabilities reputed company of this document. A Senior Associate, under the general direction of a Project reputed company 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. A Senior Associate may act in a client facing role with support from line management. reputed company serving as a Project reputed company or Work reputed company reputed company, a Senior Associate assures the work of the entire team or work reputed company is delivered on time and that it meets client’s and PC’s quality expectations.

Key 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-reputed company 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.
• 5 to 8 years of relevant experience

Educational Qualification

• B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy

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