Regulatory Affairs Specialist

The Regulatory Affairs Specialist plays a crucial role in ensuring that products meet all regulatory requirements before they reach the market. This position involves preparing submissions to regulatory agencies, maintaining regulatory compliance across various products, and working closely with other departments to facilitate smooth product launches. By effectively communicating regulatory changes and implications, the specialist minimizes risks and enhances the organization's ability to innovate within the legal framework, thus contributing to overall business objectives.

• •Regulatory Compliance Tracking

  Monitor and interpret regulatory guidelines to ensure products meet local and international compliance standards, updating teams about relevant changes in regulations and policies.

• •Documentation Preparation

  Compile, review, and submit regulatory documents required for product registrations, renewals, and audits to ensure alignment with compliance standards and facilitate market access.

• •Regulatory Strategy Development

  Develop and implement regulatory strategies for product approvals by coordinating cross-functional teams and optimizing timelines across development stages for market entry.

• •Cross-Functional Collaboration

  Collaborate with R&D, quality assurance, and manufacturing teams to integrate regulatory requirements into product development, ensuring compliance and operational efficiency.

• •Risk Assessment and Mitigation

  Conduct risk assessments related to regulatory compliance and implement mitigation strategies by analyzing potential regulatory impacts on business processes and product marketing.

• •Communication with Regulatory Bodies

  Maintain professional relationships with regulatory authorities by responding to inquiries, managing expectations, and facilitating effective communication to support product approvals.

• •Regulatory Training and Support

  Provide regulatory training and support to internal stakeholders by educating teams on compliance requirements and enhancing awareness of regulatory impacts on business operations.

• •2+ years of experience in regulatory affairs, compliance, or a related field
• •Strong understanding of relevant regulations and guidelines (e.g., FDA, EMA)
• •Experience in preparing and reviewing regulatory submissions
• •Excellent communication and organizational skills