Senior Regulatory Professional
1 week ago
KVK Tech is a dynamic and growing company, and we are seeking a highly experienced Regulatory Group Leader to join our team.
The estimated salary for this role is $140,000 per year, based on industry standards and location.
About the Position:
This is an excellent opportunity to lead the development and implementation of regulatory strategies that drive business growth and success. As a Regulatory Group Leader, you will be responsible for managing regulatory submissions, collaborating with cross-functional teams, and ensuring compliance with industry regulations.
Key Responsibilities:
- Develop and implement regulatory strategies that meet KVK Tech's business objectives.
- Lead the preparation and submission of regulatory documents in compliance with cGMP requirements, FDA regulations, and industry best practices.
- Collaborate with R&D, QC, and Production Managers to ensure seamless integration of regulatory strategies.
- Train Regulatory Associates on regulatory procedures and guidelines.
- Assist associates, coordinators, analysts, auditors, and specialists as needed.
Requirements:
- Bachelor's Degree in Pharmacy, Chemistry, or a scientific discipline preferred.
- Minimum 5 years of pharma experience preferred.
- Strong communication and problem-solving skills.
- Proficient with Adobe PDF, Microsoft Office, XML, eCTD tools, and advanced computer skills.
- Continuous working knowledge of applicable FDA/ICH/DEA regulations and cGMP guidelines.
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