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PAREXEL International Corporation Job Title
Principal Regulatory Affairs Consultant - RCS

PAREXEL International Corporation

Job Description
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Principal Regulatory Affairs Consultant - RCS
United Kingdom, Remote
Date posted
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Success Profile
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As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
Full Time
Travel: Yes
Glassdoor Reviews and Company Rating
Success Profile
Check out the top traits we're looking for and see if you have the right mix.
"When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."
Chris – Associate Director, Regulatory & Access
"In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"
Riley – Regulatory Affairs Consultant
Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Work with industry leaders and subject matter experts.
The ability to innovate, ask “what if” and try new solutions without fear of failure.
Opportunities to work on multiple accounts – never boring!
Strong management with depth of experience working for global health authorities.
Are you an experienced Clinician or Health Professional 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, EMA or MHRA 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  magazines, 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 :
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, PhD or other advanced degree 
(i.e. MBA) preferred
- 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 or EMA) is essential. 
-  Prior employment with MHRA or other health authority experience in Europe. would be desirable
- Clinical development of small molecules, biologics and preferably cell and gene therapy
- Drafting, reviewing and submitting clinical 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!
Apply Now
FAQ: Hiring during COVID-19
Learn how we recruit the best minds in these unprecedented times.
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Meet Stephanie: Associate Director, Regulatory & Access
Stephanie shares her story about her development within Parexel and what it's like to work here.
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Flexible Work Arrangement
In-office, home-based or a mix? What’s your preference? We value the work-life balance of our employees, and as such Parexel is offering maximum flexibility to our employees wherever possible.
Learn More
Our hiring process
Find out what to expect when applying to Parexel
Learn More

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