
Regulatory Compliance Specialist
17 hours ago
The primary objective of this role is to ensure regulatory compliance of company products and activities by working collaboratively with a team of regulatory professionals.
- Regulatory Strategy Development: Create and implement regulatory strategies that support the company's business objectives and adhere to relevant regulations and guidelines.
- Document Preparation and Submission: Manage the preparation and submission of regulatory documents, including regulatory filings, registrations, and certifications.
- Inspection and Audit Coordination: Coordinate and manage regulatory inspections and audits, and ensure prompt corrective and preventive actions are taken in response to any findings.
- Regulatory Updates and Communication: Stay up-to-date with changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders in a timely manner.
- Stakeholder Engagement: Foster positive relationships with regulatory authorities and other external stakeholders.
Key Responsibilities:
- Work effectively with cross-functional teams, including product development, clinical research, manufacturing, and quality assurance.
- Provide regulatory guidance and support to internal stakeholders.
- Collaborate with internal and external stakeholders to develop and implement regulatory policies and procedures.
- E nsure timely and accurate reporting of regulatory activities and metrics.
Qualifications and Requirements:
- Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy.
- At least 01 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.
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