We are recruiting an additional Regulatory Affairs Manager for our clients rapidly growing Global Regulatory Affairs team located in Dublin. The Dublin team provide regulatory operations and strategy support to their current and growing product portfolio, therapy areas and international market presence.
- Acts as responsible Senior Regulatory Team member for assigned regulatory projects
- Preparation and responsibility for regulatory submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, CMC authoring and \ or updates as required.
- Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with Corporate needs and timelines.
- Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Pharmacovigilance, Regional Regulatory Managers, Regional Heads).
- Understands the Scope of Work, timelines and deliverables for a given project.
- Manage Regulatory Projects and /or regulatory team members
- Prepare status reports and metrics for assigned projects
- Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
- Promote best regulatory practice and approach in business operations
- Promote and develop best use of regulatory tools and e-platforms
- Writing and preparation of relevant CTD (Common Technical Dossier) documents to support submissions,
in collaboration with Technical/CMC/Clinical/Labelling experts
- Relevant degree in life science-related plus at least 5 year’s relevant human pharmaceutical experience with
focus on filing and lifecycle maintenance of marketed products in Europe and/or emerging markets
- Experience of EU DCP and MRP MAAs
- Experience of emerging markets / international RoW markets and regulatory filings
- Quality control review of technical/ regulatory documents
- Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets
and filing options
- Compliance with SOPs, Change controls and regulatory best practices
- Pharmaceutical artwork review and sign-off
- Project management experience - an advantage
- Experience of Women’s and/or Men’s healthcare – an advantage
- Experience of US Regulatory Affairs – an advantage
- Experience of Medical Devices – an advantage
- Ability to work to manage busy workload encompassing several active projects
- Good team player with local Dublin based and internationally based colleagues
- Positive can-do attitude in growing company with expanding range of therapeutic product range
- Good negotiating skills and the ability to identify and resolve issues
- Excellent verbal and written communication skills
- Excellent computer skills e.g. Word, Excel, data and document management systems
- Cultural awareness for global ways of working
- Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate
- Desire to grow regulatory operational and regulatory strategy experience
- Track record of success in Regulatory Affairs international filings
Key words phrases are:
Human pharmaceuticals, Regulatory Manager, MAAs, Life Cycle Maintenance, International Regulatory Affairs, Regulatory Strategy, Team player, Dublin office based.
CV to firstname.lastname@example.org 01 2302400