Liam O’ Connor
Castlecomer
Summary
Experienced in project management and regulatory submissions, with a focus on compliance in Pharmaceuticals, Bio Pharmaceuticals and Medical Devices. Strong problem solving and communication skills to foster collaborative relationships and streamline processes. Driven by a commitment to quality and continuous improvement in highly regulated environments with the patient at the core of all activities.
Overview
14
14
years of professional experience
9
9
years of post-secondary education
Work History
Regulatory Specialist
Bayer Limited
06.2009 - 12.2011
- Project Team Management.
- Dossier Management and Preparation; Modules 1-5, eCTD and NeeS.
- Health Authority Communications and Development.
- Variation Preparation and Submission to HPRA, EMA; (eCTD and NeeS).
- Renewal Preparation and Submission to HPRA.
- PQR Project Management and Development.
- SOP and procedural preparation /ongoing review and development.
- QMS development and departmental integration.
- Product Supply Affiliate Team Management.
- MAA preparation and submission to HPRA (eCTD)
- Responses to Authority Queries (eCTD)
- Training of junior staff in department (Pharmacy Interns)
- Supply chain support.
- Responsible for over 50 Product Authorisation; (National, MRP, DCP, CP); Pharma, Consumer Care and Medical Device.
- Submission of PSUR's, ASR's for Product Authorisations.
- Preparation of promotional materials for marketed products.
- Preparation of product labelling for marketed products.
- Provision of support to marketing and medical departments.
Regulatory Specialist
Wyeth Pharmaceuticals Limited
10.2006 - 12.2008
- Management of Licence Transfers form UK Regulatory Affiliate to New Irish Regulatory Affiliate, National and CP Product Authorisations.
- Project Team Management.
- Dossier Management and Preparation.
- HSE / HPRA Communications and Development.
- Variation Preparation and Submission to; HPRA/EMA/FDA/MHRA/BfArM and MPA.
- Renewal Preparation and Submission to IMB/EMA/FDA/MHRA/BfArM and MPA.
- PQR development.
- Regulatory Department initial set up.
- SOP and procedural preparation /ongoing review and development.
- QMS development and departmental integration.
- Supply Chain Product Team Management.
- Product Management, Marketing team strategy, API development, product information training.
- IPHA employee training.
- Oversaw more than 90 product authorizations.
- Change Control coordinator for labelling updates using Trackwise.
- Artwork Change Control coordinator for Artwork and Label updates (Affiliate Artwork Labelling Coordinator)
Regulatory Affairs Officer
Niche Generics Ltd
03.2006 - 09.2006
- Generic dossier preparation and submission for market authorisation via MRP, DCP and national application procedures.
- Maintenances of Market Authorisation.
- Deficiency letter responses to various European Regulatory Authorities.
Regulatory/Compliance Officer
Wyeth Medica Ireland
02.2004 - 03.2006
- Providing regulatory support for multiple products within the company's portfolio.
- Compiling and preparing regulatory dossiers to include Marketing Authorization applications for submission to EU/EEA countries, modules 1-5, and quality overall summary.
- Review of CMC documentation, gap analysis, Developing and implementing remediation plans via internal change control and variation filing.
- Reviewing analytical method validation reports to ensure compliance with ICH guidelines.
- Use of Excel and Word templates to generate submission ready components.
- Assist in the implementation of business processes, developing guidance/procedures and working practices.
- Gap analysis and remediation planning for compliance evaluation.
- Variation and dossier CTD preparation and submission.
- Analytical method validation review in accordance with ICH guidelines.
- Stability data and report review.
- Regulatory Project Management.
- Worked in the Austrian affiliate in Vienna for 2 months during the European Compliance Project.
Senior QC Laboratory Services Chemist
Wyeth Medica Ireland
09.2000 - 02.2004
- Responsible for high priority/high risk analysis, cGMP, GLP.
- Management of technology transfers from Wyeth USA.
- Maintaining documentation in accordance with cGMP and GLP.
- Appraisal of analytical results, Trend Analysis and evaluations.
- Method development and validation.
- In process validation and stability studies.
- Chemical and physical testing, HPLC, GC, UV and IR spectroscopy.
- Calibration and performance verification of instrumentation.
- Staff training to comply with cGMP, GLP.
- Analyst training, Analytical Testing, documentation generation.
- Supervision and workload distribution to 14 analytical chemists.
R&D Chemist
Teagasc
Carlow, Ireland
02.2000 - 09.2000
- Analysis of genetically modified sugar beet.
- Quantification of sucrose and related compounds using polarisation techniques.
- Restriction digests on DNA samples.
- Use of SDS-PAGE to separate DNA fragments.
- Use blotting techniques to fix DNA sequences.
- Use of PCR to produce multiple sequences of DNA samples.
- Compiling data and preparation of technical reports.
Intern
Guinness Ireland Limited
Dublin, Ireland
01.1998 - 01.1999
- Brewing Technology, analysis of immobilised yeast cells in continuous fermentation.
- HACCP system design and implementation system for new brewing technology.
- Pilot and scale up fermentation.
- Flavour analysis by HPLC and GC.
- Yeast Cell culture.
- Use of agarose gel electrophoresis.
- Use of molecular biology techniques to isolate and amplify DNA.
Education
Bachelor of Science Honours Degree - Industrial Biology, Biochemistry with Microbiology
Institute of Technology Carlow
Carlow 09.1997 - 06.1998
Certificate. - Sales And Marketing
City And Guilds Of London (Dublin)
09.1996 - 06.1997
Higher National Diploma Science - Food Quality Management
Institute of Technology Carlow
Carlow 09.1996 - 06.1997
National Certificate in Science - Food Technology
Dublin Institute of Technology
09.1993 - 06.1995
Leaving Certificate - Irish, English, Maths, Biology, Business Organisation, Accounting, Home Economics
Castlecomer Community School
Kilkenny 09.1988 - 06.1993
Certificate - Public Speaking
Irish Academy of Music
09.1989 - 06.1990
Skills
- Communication and Advocacy
- Time Management and Organisation
- Problem-Solving and Crisis Management
- Emotional Intelligence and Empathy
- Adaptability and Flexibility
- Financial and Project Management
- Resilience and Stamina
- Sense of Purpose
- Commitment and Dependability
- Health Authority Communication
- Regulatory Compliance
- Dossier Preparation
- Quality Management Systems
- Project Management
- Change Control
- Analytical Method Validation
- Training and Development
- Team Collaboration
- Cross-functional Support
- Deficiency Response Management
- Compliance and Auditing
- Report-Writing
- Staff Training
- Documentation Management
- Health Authority Inspection
- Risk Assessment
- Cross-Functional Collaboration
- Analytical Review
- Client Relationship Management
- Timely Reporting
- Compliance Systems
- Technical Communication
- Compliance Development
- Computer Literacy
- Health and Safety Compliance
- Time Efficiency
- Public Speaking
- Regulatory Compliance Remediation
- Quality Assurance
- Analytical Thinking
- Technical Report Writing
- Quality Control Analysis
- Quality Control Analytical Chemistry
- Product Quality Review
- Risk Mitigation
References
Available upon request
Training
- IPHA Code Training 2025/26
- EMA New Medicines Legislation 2026.
- HPRA New Variation Legislation 2026.
- Pharmaceutical Ireland, Strategic Regulatory Affairs.
- Reading Scientific Services, Practical Equipment Qualification And Method Validation.
- Wyeth Medica Ireland, Train the Trainer Certification.
- Lean Six Sigma, Yellow Belt.
Current Occupation
Since January 2012 I have been a Full-Time Family Carer for my elderly parents. I am now ready and eager to return to full time employment.
Personal Information
Hobbies: Breed and train Scottish Terriers., History, Irish Literature, Travel, Athletics, Hurling., Interested in classical music, regularly attend concerts at the NCH.
Languages
English
First Language
Timeline
Regulatory Specialist
Bayer Limited
06.2009 - 12.2011
Regulatory Specialist
Wyeth Pharmaceuticals Limited
10.2006 - 12.2008
Regulatory Affairs Officer
Niche Generics Ltd
03.2006 - 09.2006
Regulatory/Compliance Officer
Wyeth Medica Ireland
02.2004 - 03.2006
Senior QC Laboratory Services Chemist
Wyeth Medica Ireland
09.2000 - 02.2004
R&D Chemist
Teagasc
02.2000 - 09.2000
Intern
Guinness Ireland Limited
01.1998 - 01.1999
Bachelor of Science Honours Degree - Industrial Biology, Biochemistry with Microbiology
Institute of Technology Carlow
09.1997 - 06.1998
Certificate. - Sales And Marketing
City And Guilds Of London (Dublin)
09.1996 - 06.1997
Higher National Diploma Science - Food Quality Management
Institute of Technology Carlow
09.1996 - 06.1997
National Certificate in Science - Food Technology
Dublin Institute of Technology
09.1993 - 06.1995
Certificate - Public Speaking
Irish Academy of Music
09.1989 - 06.1990
Leaving Certificate - Irish, English, Maths, Biology, Business Organisation, Accounting, Home Economics
Castlecomer Community School
09.1988 - 06.1993