Senior Regulatory Affairs Specialist

Description:

Our client seeks a Regulatory Affairs professional to join their employees around the world who work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

The role will be within the Regulatory Affairs Department. Regulatory Affairs is core to delivering product pipeline via management of global submissions for both New Chemical Entities (NCE’s) & New Molecular Entities (NME’s) and global post approval change management for commercial products, thus ensuring reliable supply and continuous improvement.

Purpose:

The purpose of the Principal Scientist- Global Regulatory Affairs-CMC role is to provide strategic, tactical and operational direction to expedite CMC development of the portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions.

This position is a hybrid role, Cork Ireland.

Responsibilities:

• Will oversee the preparation and documentation of specified regulatory submissions
• Provide regulatory leadership and direction for products listed as primary responsibilities
• Manage submission timelines, monitor approval status and communicate change status to interested personnel in a timely manner
• Will have a good understanding of existing and emerging pharmaceutical & biotech-related regulations
• Provides the necessary CM&C commitment information to site personnel
• Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)

Minimum Qualification Requirements:

• Level 8 Bachelor's degree in sciences discipline (e.g. chemistry, biology, biochemistry or pharmacy or related scientific discipline) required.
• Prior Regulatory CMC experience (3-7 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.
• Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered.