Regulatory Affairs Officer

• Regulatory Compliance: Ensure that all products meet regulatory requirements for safety, efficacy, and quality as defined by local and international regulations (e.g., FDA, EMA, ISO).

• Documentation Preparation: Prepare and submit regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and other submissions as required.

• Liaison with Regulatory Authorities: Act as the primary contact with regulatory agencies, addressing inquiries and facilitating communication regarding product submissions and compliance issues.

• Monitoring Regulatory Changes: Stay updated on changes in regulations and guidelines affecting the life sciences industry and assess their impact on the company’s products and processes.

• Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Marketing teams to ensure that regulatory considerations are integrated into product development and marketing strategies.

• Training and Guidance: Provide training and guidance to internal teams on regulatory requirements and best practices.

• Risk Assessment: Conduct risk assessments related to regulatory compliance and develop strategies to mitigate potential issues.

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s degree preferred).

• Proven experience in regulatory affairs within the life sciences industry.

• Strong knowledge of regulatory guidelines and processes.

• Excellent communication and interpersonal skills.

• Detail-oriented with strong analytical and problem-solving abilities.

• Ability to work independently and as part of a team.

• Proficiency in relevant software and tools for regulatory submissions.

Quantabase Technologies