Senior Consultant

The Senior Consultant is responsible to lead the regulatory strategy to support registration (new and maintenance) in Europe and Internationally for drugs, and biologics and additionally be responsible for the strategic approach to securing new business, facilitating issue resolution, ensuring project/program timelines/budgets are met. You will also maintain client relationships to support of future business as the position participates in business development activities. This position may or may not have direct reports.,

• Effectively manage/execute/oversee the preparation of regulatory submission documents demonstrated by a deep knowledge of applicable legislation and guidelines for submission to government agencies and continued client compliance.


• Facilitate submission approvals and amendments through leading communications (face to face meetings, teleconferences, etc.) and negotiations with client, government agencies, and project teams. Build positive working relationships with clients, and government agency contacts.


• Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organisation as required. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.


• Responsible for managing workflow including prioritising project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.


• Lead, participate in and support project teams, and advise other departments on regulatory issues and strategies related to EU filings and maintenance activities across a broad range of product types.


• Effectively prioritise and complete multiple projects within established timeframes and within budget.


• Train, coach, and develop assigned individuals to establish team expertise across various product types (preparation of files, regulatory strategy, client management, agency/client communications and project management).


• Enthusiastically monitors for new regulatory requirements and shares key findings.


• Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.


• Publish and/or present at training seminars or lead workshops at industry conferences. Participate actively in other business related projects (business opportunities, client specific issues etc.)
  
  Thorough working knowledge of local and global Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines.


• Effective project management skills.


• Through knowledge of budgetary and financial management (budget, development, time and cost, forecasting, revenue, margin, profit and loss, invoicing, etc.).


• Knowledge of business development process.


• Ability to develop and maintain excellent rapport with clients.


• Demonstrable good problem solving, judgement, and decision-making skills to motivate staff to seek creative solutions to issues surrounding timely, on-budget, and quality delivery. Focuses on resolving problems and makes decisions in a timely manner.


• Ability to make decisions independently and operate autonomously.


• Sound listening, conflict management, and negotiating skills.


• Excellent planning, organisation, interpersonal, time, and change management skills.


• Highly motivated and proactive.


• Shown ability to understand, and communicate corporate policies and procedures.


• Proficiency in all MS-Office applications, including Word, Excel, Powerpoint.


• Excellent verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding.


• Problem solving skills balanced with an awareness of business objectives. Good judgement in the face of difficult and unclear situations.


• Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation.


• Planning and organisation: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively. Has a routine or system for completing work., Bachelors degree in a relevant discipline, preferably in a life sciences, or other healthcare field.


• Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.


• Certification in regulatory affairs (RAC) or post-secondary institution beneficial.


• Relevant experience i.e. pharmaceutical, biologics, medical device with regulatory experience in the local environment (Europe).


• Experience supporting business development activities and people management an asset.


• Experience presenting at applicable industry conferences and/or publications in regulatory affairs.
  
  At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.


Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.