Principal Scientist- Global Regulatory Affairs

Job title:

Principal Scientist- Global Regulatory Affairs

Company

Hero Recruitment

Job description

In this role you will make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives.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.The purpose of this role is to provide strategic, tactical and operational direction to expedite our client’s portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions.
These activities are accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence. coupled with a strong technical knowledge of CMC development and manufacturing processes.Responsibilities:

• Will oversee the preparation and documentation of specified regulatory submissions
• Provide regulatory leadership and direction for products listed
• Will develop, plan and execute appropriate regulatory strategies and priorities through effective partnership with other departments such as process and technology transfer, manufacturing, quality control and quality assurance
• 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
• Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)
• Review and/or approval of regulatory changes, regulatory deviations, proposals for reprocessing, validation and stability protocols

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 related field (5-7 years) will also be considered.

For further information on this role please contact Regina Carroll call 086 0100 903 or email jobs@hero.ieCheck out all our open jobs on our HERO Recruitment website – https://www.hero.ie/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 standards 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 you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Expected salary

Location

Limerick

Job date

Sat, 24 Aug 2024 23:45:02 GMT

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