Head of Global Regulatory Affairs, Dublin, Ireland
Acorn_Reg Company Confidential
Acorn Regulatory has been exclusively retained by a global pharmaceutical company to identify and recruit a Head of Global Regulatory Affairs for their facility in Dublin, Ireland.
This is a unique opportunity to build and lead a team of regulatory specialists with a global pharmaceutical company.
Our client is a globally trading firm with facilities across the world. They have a well-deserved reputation as the market leader in their product category, with significant sales in territories such as the USA, Europe and Asia.
In recent years they have experienced significant success with elements of the product portfolio in a number of ‘new territories’. They have built up a large and well respected workforce in countries such as the USA, Canada, China and elsewhere.
The successful candidate will be tasked with developing and implementing a global regulatory strategy to enable the company to maximise their revenue in their target markets. The Head of Global Regulatory Affairs will lead a team of in-house specialists and external consultants to ensure that our client company can continue to grow their business.
The successful candidate can expect a market leading salary and benefits package. As this is a new role, we, along with our client, are willing to tailor a package to best suit the needs of the role holder.
The Head of Global Regulatory Affairs (GRA) will establish the centre of excellence for regulatory affairs with the aim to drive efficiency across regulatory functions. The role holder will drive the design and implementation of strategic and tactical process change initiatives in a manner that creates consistency and efficiency.
The role holder will be responsible and accountable for all operational activities including training, budget and special projects related to the daily activities of GRA. He/she will oversee and ensure overall compliance within GRA.
Head of Global Regulatory Affairs
• The Head of Global Regulatory Affairs will create vision, strategy and goals for achieving operational excellence within. He / she will identify operational gaps in execution, prioritize, plan, and drive cross functional projects within agreed timelines
• Oversees, coordinates and executes the GRA accountabilities
• Owns the budgetary responsibility for Regulatory Affairs, prepares department budgets and identifies appropriate external resources as needed
• Ensure that each project initiates with clearly articulated ‘terms of engagement’, has well defined and measurable business results, and is delivered on-time, on-budget and within scope
• Accountable for ensuring training is adequately assessed and performed within GRA
• Ensure that regulatory activities are supported by robust procedures
• Provide expertise across global regulatory teams to ensure most efficient processes are implemented and followed
• Work with the board of the company to identify and manage new regulatory projects
• Develop SOPs and processes for GRA
• Ensure that the regulatory department has/maintains up to date knowledge to meet all country and region-specific regulatory requirements
• Responsible for operational excellence and continuous improvement
• Establish, develop and manage internal talent ensuring a balance between internal resources and use of external vendors to ensure flexibility in the delivery of simultaneous submissions globally
• Experience in the pharmaceutical industry with 10 years regulatory affairs management experience in regulatory operations
• Experience of managing staff in a global matrix organization
• Self-motivated, flexible and creative leader, able to prioritize, multi task and work in a fast-paced and demanding environment
• Strong communications skills: oral, written, with proven negotiation skills, and time-management
• A critical logical thinker with the ability to analyse problems, identify alternative solutions and implement recommendations for resolution
• Sound understanding of information management concepts and tools needed to carry out Regulatory Operations priorities
• A proven ability to work under pressure and adhere to deadlines
How to Apply
This role is being managed exclusively by Acorn Regulatory.
If you would like to have an initial confidential discussion regarding the role then please contact Brian Cleary at Acorn Regulatory on 00353 52 61 76 706.
Alternately, if you would like to submit your up to date CV for consideration, then please email: firstname.lastname@example.org
All applications will be treated in the strictest of confidence.