Senior Regulatory Affairs Associate

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company 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 reputed company 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 reputed company work is performed, and delivered on time, meeting the reputed company expectations of PC and the reputed company. A Senior Associate may reputed company in a reputed company 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 reputed company’s and PC’s reputed company expectations.

Key Responsibilities

• Support global regulatory lifecycle management activities across EU, US, and international markets
• Contribute to regulatory reputed company 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 reputed company responses
• reputed company submission management support including planning, coordination, and reputed company 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

Apply To This Job