Reg Affairs Coordinator

The role:

PE Global is currently recruiting for a QA Reg Affairs Coordinator on behalf of a leading pharmaceutical company based in Cork. This is a fixed term 12 month contract.

Responsibilities:

• Support regional leads and local teams with the coordination, communication, planning, preparation and submission of site GMP and compliance-related content pertaining to Marketing Application(s) and Establishment Licenses for initial/renewal applications in Global markets aligned with regulatory strategy.
• Be the point of contact between Local Regulatory Teams and SMEs/CMOs to support GMP/site registration submissions.
• Coordinate Power of Attorney and other signature/legalization process
• Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.
• Support regional leads and local teams with the creation of timelines and tracking deliverables to timelines to ensure timeline submissions aligned with program milestones.
• Update relevant dashboards on progress of regulatory document preparations working closely with Regulatory and Quality partners Ensuring consistent and appropriate communication within the department and with other functional areas.
• Interfacing with global Regulatory partners, internal cross functional teams, and consultants.
• Attending relevant functional area and project team meetings Process documentation requests to support key application activities Assisting in the timely preparation for interactions with global regulatory authorities.
• Initiate request for Agency issued documentation (e.g. FDA Certificates of Pharmaceutical Product, Site Manufacturing Licenses), notarization, and legalization, when applicable.
• Maintain system for Regulatory CPP/CMP and Document Authentication Requests Track GMP / site registration renewal timeline together with local teams

Education and Experience:

• BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.
• At least 2 years of experience in Regulatory Affairs or a related function such as Quality, Process Development in a global Pharmaceutical and/or Biotechnology Company (preferably with exposure to both development and commercial phases of product lifecycle).
• Outstanding interpersonal and communication (written and verbal) skills is required.
• Strong writing and editing skills for technical documentation.
• Project management skills are a plus.
• Proficient with computer and standard software programs.
• Ability to work across the Global time zones

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***