
Regulatory Strategy and Compliance Lead
4 days ago
Role Description:
The Regulatory Coordinator will work as a team member of regulatory professionals to ensure regulatory compliance of company products and activities. This includes preparing and submitting regulatory documents, managing regulatory inspections, and developing regulatory strategies.
Responsibilities:
- Work collaboratively with regulatory professionals to provide effective and efficient regulatory support for the company's products and activities.
- Develop and implement regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelines.
- Prepare and submit regulatory documents, including filings, registrations, and certifications.
- Coordinate and manage regulatory inspections and audits, and ensure appropriate corrective actions are taken in response to any findings.
- Stay up-to-date on changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders.
- Build and maintain positive relationships with regulatory authorities and other external stakeholders.
- Provide regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance.
- Collaborate with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectives.
- Ensure timely and accurate reporting of regulatory activities and metrics.
Requirements:
- Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy.
- 1 year of experience in regulatory affairs, fresh graduates will also be preferred.
- In-depth knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated products.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to work independently and manage multiple projects simultaneously.
- Strong attention to detail and accuracy.
- Experience working in a fast-paced, deadline-driven environment.
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