Global Regulatory Affairs - Principal 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:
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.
Have a good understanding of existing and emerging pharmaceutical & biotech-related regulations.
Provide the necessary CMC commitment information to site personnel.
Ensure compliance of GMP documents to regulatory commitments and provide 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.
For more on this contact Regina at HERO or
.
HERO Recruitment website –
Please Note:
Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Data can only be transferred outside of the EEA on the basis of standard contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.
You have supplied us with your personal data in the process of applying for a position.
Our client company may have personnel outside of the EEA who will review your data.
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