Principal – Strategic Regulatory Services
Location: Any EU country
ICON plc, a leading Clinical Research Organisation, employing 14,500 people across 97 offices in 38 countries - our mission is to help our clients to accelerate the development of drugs and devices that save lives and improve the quality of life!
The Principal SRS will lead the regulatory strategy to support registration (new and maintenance) in Europe and Internationally for drugs and biologics, and 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 in the support of future business as the position participates in business development activities. This position may or may not have direct reports.
Responsibilities and Accountabilities:
- 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.)
Knowledge/Skills/Attributes
- 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.
Education/Experience
- 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.
Benefits of Working in ICON:
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are he key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career!
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ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment