Senior Consultant - Strategic Regulatory Services
About the role
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- 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 build 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.
- Ability to make decisions independently and operate autonomously.
- Sound listening, conflict management, and negotiating skills.
- Excellent planning, organisation, interpersonal, time, and change management skills.
- 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 develop and maintain excellent rapport with clients.
- Highly motivated and proactive.
- 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.
- Shown ability to understand and communicate corporate policies and procedures.
- 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 clear situations.
- 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.
- Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation.
- Proficiency in all MS-Office applications, including Word, Excel, Powerpoint.
- 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.
- Relevant experience i.e. pharmaceutical, biologics, medical device with regulatory experience in the local environment (Europe). Relevant experience in any Therapeutic Area will be considered; experience in Oncology is considered advantageous.
- Experience supporting business development activities and people management an asset.
- Experience presenting at applicable industry conferences and/or publications in regulatory affairs.
- Certification in regulatory affairs (RAC) or post-secondary institution beneficial.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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