Regulatory Affairs Consultant (Project Management )

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

This role can be either office based in Dublin or Uxbridge or you can be fully home based anywhere in the UK or Ireland. The offices are open planned, and you will be working in an innovative and collaborative environment connecting with colleagues from around the world. This role can also be office based or home based in the following countries: Czech Republic, France, Hungary, Italy, Lithuania, Netherlands, Poland, Serbia, Spain, Romania

This Senior Regulatory Affairs Consultant will focus on project leadership and be responsible for leading long-term large regulatory affairs outsourced projects potentially including MAT projects, product lifecycle maintenance projects, global MAA/NDA application projects or any project that supports client regulatory affairs requirements.

As the Senior Consultant you must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, profound knowledge within a business context of what services we provide. You will develop specialist knowledge of a particular subject matter or market. You will also provide a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. You will also serve as either an individual contributor, a workstream lead or provide overall project leadership and guidance to project team members on technical/process issues.

Key Accountabilities:

Project Execution

- Works within a team environment or individually based on the project needs

- Works within broad project guidelines and facilitates issue and conflict resolutions

- As a Project Leader, provides overall project leadership

Consulting Activities and Relationship Management

- Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements

- Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear

- Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction

Business Development

- Maintain and continue to grow a network of industry colleagues through relationships formed during project engagements or through other industry experience

- Actively participates in project scoping calls and proposal preparation

- May deliver sales presentations and participate in bid defense meetings when needed

Parexel related responsibilities

- Meets established metrics as specified in scorecard on an annual basis

- Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by managementQualifications

Education:

- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

Skills:

- Project leadership and management knowledge

- High-level consulting skills

- Critical thinking and problem-solving skills

- Excellent interpersonal and intercultural communication skills, both written and verbal

- Client-focused approach to work

- Results orientation

- Teamwork and collaboration skills

- Proficiency in local language and extensive working knowledge of the English language

- Networking

- Business analysis

- Self-confidence and control

Knowledge and Experience:

- Previous CRO / Pharma / Regulatory Agency experience acting in the capacity of a Regulatory Affairs Consultant or Senior Regulatory Affairs Consultant is important.

- Client-focused approach to work (Quality)

- Regulatory Project Management/Lead experience is important

- Knowledge and Experience of regulatory affairs activities including lifecycle maintenance, supporting / coordinating Marketing Authorisation Transfers (MATs) and/or global MAA / NDA role out is beneficial.

- Project management qualification would be a plus.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.Apply today to begin your Parexel journey!