Principal Regulatory Affairs Consultant - RCS

Parexel International Corporation

United Kingdom - Any Region - Home Based

Are you an Industry experienced Primary Care, Internal, or General Medicine Physician who is dedicated to Public Health? Committed to making a difference in the lives of patients? And looking for an opportunity to use your clinical expertise across a variety of Therapeutic Areas? But you feel like you’ve hit a ceiling professionally and you’re unsure of the next step in your career… Well, Parexel Consulting is growing and we're seeking experienced Clinical professionals just like you who are passionate about drug development and who are looking for opportunities to stretch your thinking, advance professionally, and present/execute solutions for our clients.

Now is the time to join this DYNAMIC Group within our Parexel Regulatory Services Team! As a Principal Consultant you will provide expertise, solutions, and strategy to various clients on exciting products in various stages of development. You will work alongside a distinguished team of Subject Matter Experts who have a wealth of Industry and FDA experience, along with a wide variety of Technical Expertise!

As a Principal Regulatory Affairs Consultant within the Parexel Consulting Organization you must be a nationally recognized professional in your field of expertise with well-developed and proven consultation skills. You must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as an extensive knowledge of what services PC provides. You will provide a full range of consulting services and work within your personal area of expertise. You will provide mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within PC.

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, Belgium, Croatia, Sweden, Denmark, Norway, Finland, Hungary, Italy, Lithuania, Netherlands, Poland, Serbia, Spain, Romania

Key Accountabilities:

Project Execution

- Works within a team environment or individually based on the project needs as a Project Leader, provides overall project leadership:

- Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project

- Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)

Thought Leadership

- Delivers presentations at seminars and industry group meetings Authors articles for publication in industry agazines, newsletters, book chapters and other forums

- May serve as a member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations.

Consulting Activities and Relationship Management

- Applies the appropriate organization’s consulting models and methodologies and assists in the design/improvement the methodologies when needed

- Provides a full range of technical and/or business consulting services within personal area of expertise including representing clients to regulatory agencies

Business Development

- Actively prospects and leverages new business opportunities with client and industry contacts in collaboration with Account Management

- Presents information about PC service offerings reflecting the organization’s capability to support client needs

Parexel related responsibilities

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

Education:

- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, PhD or other advanced degree

(i.e. MBA) preferred

Skills:

- High-level consulting skills

- Critical thinking and problem-solving skills

- Project leadership and management knowledge

- 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

- Account planning and support

- Networking

- Business acumen and analysis

- Self-confidence and control

Knowledge and Experience:

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

- Advanced experience with expert level industry or regulatory knowledge; experience with a regulatory agency (such as FDA, MHRA) is essential.

- Prior employment with MHRA or other health authority experience in Europe. would be desirable

- Nonclinical development of small molecules, biologics and preferably cell and gene therapy

- Drafting, reviewing and submitting nonclinical sections of IND, NDA, BLAs

- Project Management/Lead experience is important

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!

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2022-07-13 00:05:22


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