Regulatory Affairs Consultant

Description:

Our client is specializing in customized technology solutions, the company focuses on enhancing operational efficiency and performance across diverse industries. Their services encompass software development, IT consulting, cybersecurity solutions, and managed IT services. They are committed to delivering innovative solutions tailored to specific client needs, promoting sustainable growth and operational excellence through advanced technology.

The consultancy focuses on major life sciences players and primarily servicing global TOP80 organisation.

The company is a leading provider of specialized regulatory consulting services within the life sciences industry. Their team is dedicated to ensuring compliance with global regulatory requirements and enhancing product safety and efficacy.

Position Summary: The Regulatory Consultant will play a crucial role in guiding clients through regulatory processes and requirements. Responsibilities include providing strategic advice, developing regulatory strategies, and assisting in preparing and submitting regulatory submissions to health authorities.

Key Responsibilities:

• Developing and implementing regulatory strategies to support product development and commercialization.
• Advising clients on regulatory requirements, including FDA, EMA, and other global regulations.
• Preparing and reviewing regulatory submissions, including INDs, NDAs, BLAs, and other relevant documents.
• Conducting regulatory assessments and gap analyses to ensure compliance with current regulations.
• Monitoring and interpreting regulatory changes and trends, and communicating updates to clients.
• Collaborating cross-functionally with internal teams and external stakeholders to achieve regulatory objectives.
• Supporting regulatory inspections and audits as needed.
• Providing training and guidance on regulatory matters to clients and internal teams.