Regulatory Specialist
il y a 6 jours
Job Summary:
We are seeking a highly skilled Regulatory Specialist to join our team at Planet Pharma. As a key member of our Regulatory department, you will be responsible for ensuring the timely and quality delivery of site activation readiness within assigned countries/sites.
Key Responsibilities:
- Prepare and submit Clinical Trial Application Forms and submission dossiers to regulatory authorities, ensuring compliance with local requirements and international regulations.
- Interact with regulatory authorities to address study-related queries and handle responses.
- Provide regular updates on regulatory submissions to the Start Up Lead, Regulatory Lead, and Project Manager/Team.
- Maintain project plans, trackers, and regulatory intelligence tools to ensure alignment with regulatory requirements.
- Partner with site CRAs to ensure effective communication and secure site activation.
Requirements:
- Strong knowledge of international and local/national regulations, company SOPs, and ICH-GCP principles.
- Excellent communication and project management skills.
- Ability to work independently and as part of a team.
What We Offer:
At Planet Pharma, we offer a dynamic and supportive work environment, opportunities for professional growth, and a competitive compensation package.
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