
Regulatory Affairs Specialist
13 hours ago
We are seeking a skilled professional to support global market submissions.
Regulatory Affairs SpecialistThis is an exciting opportunity for detail-oriented individuals who thrive in fast-paced environments and enjoy supporting end-to-end submission processes.
Key Responsibilities:
- Prepare regulatory documents and evaluate changes in compliance with global requirements.
- Contribute to Lifecycle Management (LCM) activities by helping to compile and review dossier modules.
- Compile initial dossiers for various countries, including US, EU, SA, WHO, ANZ, and others.
- Develop regulatory strategies and 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.
- Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process & analytical validations, batch analysis data, and stability data.
Required Skills and Qualifications:
- Minimum 3 years of experience in managing global submissions, variations, and full LCM deliverables.
- Familiarity with Veeva Vault RIM.
- Proficient in ICH guidelines and regulatory requirements for global markets.
- Ability to review technical documents from manufacturing sites for dossier sections/variations.
- Hands-on experience in initial dossier compilation for global markets.
- Experience in providing regulatory strategies and evaluating post-approval changes.
- Compilation and submission of variations/supplements as per applicable regulatory guidelines.
Benefits:
This role offers a unique opportunity for professional growth and development in a dynamic industry. If you are a motivated individual with excellent communication skills, we encourage you to apply.
What We Offer:
We provide a competitive compensation package, comprehensive benefits, and opportunities for career advancement.
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