Regulatory affairs

•	Managing a team responsible for strategical regulatory submissions including variations to FDA, EMA, TGA, Swisshealth and other worldwide regulatory authorities.
•	Submission of a full new product dossier to the EMA and supervision of policy 0070.
•	Preparation of strategic submission of generic products.
•	Collaboration in due diligence for international stakeholders.
•	Liaising with I+D for maintaining IMPDs up to date and submission to the authorities.
•	Supervising clinical trials worldwide and liaising with CROs.
•	CMC responsible person. Strategical  supervision of submission of  Module 3, ASMF, OQSs, gap analysis EMA vs. FDA

•	Contribute to the development and implementation of legislative proposals.
•	Assessing variations for chemicals and biological products
•	Regulatory and procedural management of procedures with completing milestones within procedural time lines (supervision of the procedure from receipt to finalisation).
•	Cooperation with the EMA Product Lead or the Quality Specialist Risk Management Specialist to estimate procedural complexity and strategy for handling of relevant procedures.
•	Provision of regulatory and procedural support and guidance to (co-)rapporteurs, applicants and the EPL/QS/RMS within the scope of allocated procedures. Act as a primary contact point on procedural aspects for the European Commission.
•	Ensure that the scientific aspects of the assessment are captured in the procedure, e.g. similarity assessment, paediatric requirements, new active substance status confirmation, etc.
•	Contribute to preparation of relevant documents to be published for allocated procedures following the Commission Decision, as well as contributing to the preparation of other communication documents (e.g. Lines to Take, Press Release, Question & Answer), as appropriate.
•	Update and discuss regulatory procedural related issues.
•	Participate in meetings with Applicants/Marketing Authorisation Holders and interested parties, including pre-submission meetings.
•	Contribute to the continuous Process Improvement of the service's primary procedures through the preparation and review of internal Standard Operating Procedures, Work Instructions and templates and the writing and updating of internal and external guidance documents.
•	Provide input as required to the development/update  of  regulatory  guidance.

•	Managing registration procedures as Product Team Leader or PT Member including new applications and variations for chemical products.
•	Contributing to pre-submission and scientific advice meetings for SMEs.
•	Liaising with rapporteur, MAH, CHMP, Quality Working Party and expert groups.
•	Preparing scientific reports on Quality–related aspects as part of the EMA. Peer Review of Rapporteurs’ reports on chemical products including similarity of orphan products.
•	Preparing reports for formulation-related issues for chemical products in the context of Paediatric Investigation Plans (PIPs), and to coordinate the discussions and prepare conclusions following review by the Formulations Subgroup of PDCO.
•	Participating in across products review activities.
Secretariat support to the appropriate Working Party and ad-hoc group, in relation to specific projects. 
•	Providing scientific support to the Human Medicines Special Areas sector for quality issues.
•	Preparing standard operating procedures and contribute to the preparation of guidelines, position statements.
•	Dealing with Quality related external enquiries.
•	Contributing to the Integrated Quality Management System and process improvement activities.i.e. responsible for the new geriatric initiative in the quality sector and coordinating the reflection paper on medicines for older people.

•	Carrying out the assessment of quality data of the Module 3, including ASMFs and CEPs ,provided in initial marketing authorisation for centralised, MRP and DCP procedures and variation applications making appropriate recommendations and decisions in line with the protection of public health. 
•	Writing quality scientific assessment reports. 
•	Present objective scientific assessments or other scientific papers to expert advisory bodies.
•	Contributing to policy and centralised, mutual recognition and decentralised procedures.
•	Providing scientific advice for quality issues within and outside the agency.

•	Evaluating the quality aspects of applications for product licenses.
•	Working with various aspects of drug registration.
•	Providing guidance on pharmaceutical aspects of parallel imports to colleagues within the Unit.
•	Providing guidance to other departments within the Agency and to the industry.
•	Helping implement the European single market in pharmaceuticals.

•	Monitoring compliance for the time periods for the referrals to the CMDh.
•	Maintaining a database for regulatory and scientific agreements.
•	Supporting the CMDh sub-group (SPC Harmonization, Paediatric regulation, Pharmacovigilance)

•	Preparing dossiers for submission to the Irish Health Authority (renewals, batch specific requests, variations)
•	SmPC and PL revisions
•	Initiating the roll out of a new regulatory data base  

Managing pharmacist

•	Developing strategies.
•	Training staff.
•	Liaising with local pharmaceutical companies.
•	Distribution of medicines.

Pharmacy Manager

Trainee Pharmacist