Regulatory Compliance Specialist
4 dni temu
About Randstad
Randstad is a leading human resources consulting firm that provides temporary, permanent and temporary-to-permanent staffing solutions.
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring compliance with regulations and interpretations of regulatory agencies.
Key Responsibilities:
- Operational Submission Management: Develop and implement strategies to ensure timely and efficient submission management, including planning, coordination, and execution of submissions.
- Regulatory Submissions: Prepare and submit high-quality regulatory documents, such as dossiers, reports, and other submissions required to support product development, registration, and compliance.
- Collaboration: Work closely with cross-functional teams, including research and development, quality assurance, and manufacturing, to ensure alignment and effective communication.
Requirements:
- Relevant Experience: Minimum 3 years of experience in regulatory affairs, with a strong background in pharmaceutical regulations.
- Knowledge: In-depth knowledge of pharmaceutical regulations, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
- Skills: Excellent communication, project management, and analytical skills, with the ability to work effectively in a fast-paced environment.
What We Offer:
- Competitive Salary: A competitive salary package, commensurate with experience.
- Benefits: Comprehensive benefits package, including medical, dental, and vision coverage.
- Professional Development: Opportunities for professional growth and development, including training and mentorship programs.
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