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. 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 reputed company of this document. An 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. The guidance of more senior staff may be needed to accomplish more reputed company tasks. An Associate may act in a client facing role with clear guidance and support from line management.
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.
- 2 to 4 years of relevant experience
Educational Qualification
- B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
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