
Regulatory Affairs Specialist
12 hours ago
Overview:
We are seeking a highly skilled Regulatory Affairs Specialist to support the development and implementation of regulatory strategies for our organization.
Responsibilities:
- Develop, implement, and maintain regulatory compliance programs to ensure adherence to global regulatory requirements.
- Collaborate with cross-functional teams to develop and maintain regulatory documents, including submissions, variations, and full lifecycle management deliverables.
- Provide regulatory guidance and expertise to support the development of new products and services.
- Conduct evaluations of post-approval changes considering ICH and country-specific guidelines.
- Manage compilation and submission of variations/supplements for global markets.
- Utilize Veeva Vault RIM to track queries and manage submission workflows.
Requirements:
- 3+ years of experience in managing Initial submissions, Variations, and full Lifecycle Management deliverables for the global markets.
- Must have experience with Veeva Vault RIM.
- Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
- Review of technical documents from manufacturing sites required for compilation of dossier sections/Variations.
- Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
- Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements.
- Compilation and submission of Variations/supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.
Why Work With Us?
Our organization offers a dynamic work environment with opportunities for growth and professional development. We are committed to fostering a culture of collaboration, innovation, and excellence.
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