Biotech Regulatory Liaison Officer

Job Description

We are seeking a highly skilled and detail-oriented Biotech Regulatory Liaison Officer to join our team. This role is critical in ensuring that our biotech products comply with all applicable regulatory requirements. The ideal candidate will coordinate and manage interactions with regulatory authorities, support the development and registration of biotech products, and ensure compliance throughout the product lifecycle.

Key Responsibilities:

• Serve as the primary point of contact between the organization and regulatory authorities, including the FDA, EMA, and other global regulatory agencies.
• Develop and execute regulatory strategies for biotech product submissions, approvals, and compliance.
• Prepare, review, and submit regulatory documentation, including INDs, NDAs, BLAs, and other required filings.
• Monitor regulatory requirements and changes in legislation, ensuring timely updates to internal teams and processes.
• Collaborate with cross-functional teams, including R&D, clinical, and manufacturing, to gather necessary documentation and ensure regulatory compliance.
• Provide guidance and training to internal teams on regulatory requirements and best practices.

Qualifications:

• Bachelor’s degree in Biotechnology, Life Sciences, or a related field (advanced degree preferred).
• Proven experience in regulatory affairs, specifically within the biotech industry.
• Strong understanding of regulatory requirements and guidelines for biotech products in major markets (e.g., US, EU).
• Excellent communication and interpersonal skills to manage interactions with regulatory authorities.
• Ability to work collaboratively with cross-functional teams and manage multiple projects simultaneously.

Benefits:

• Competitive salary and performance bonuses.
• Comprehensive health, dental, and vision insurance.
• Opportunities for professional development and career advancement.
• A dynamic and supportive work environment focused on innovation.

How to Apply:
Interested candidates are encouraged to submit their resume and cover letter detailing their relevant experience.