Principal Scientist Regulatory Affairs

A Principal Scientist Regulatory Affairs is needed by CareerWise Recruitment for our Cork based pharmaceutical and biopharmaceutical client. The person will drive the CMC development of company products through all stages of clinical trial, registration and submissions. Hybrid mix of onsite and remote considered. 

Role of this position

* 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)

JOB REQUIREMENTS

* Level 8 Bachelor's degree in sciences discipline (chemistry, biology, biochemistry or pharmacy or related scientific discipline) required.

* Prior Regulatory Pharmaceutical CMC experience (3-5 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.

Please call Ken Murphy today for further information on 021-4297538 or email: kmurphy@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.