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Principal Regulatory Affairs Consultant

Employer
Parexel
Location
Croatia
Salary
Competitive
Start date
25 Dec 2021
Closing date
23 Jan 2022

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

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, Croatia, Hungary, Italy, Lithuania, Netherlands, Poland, Serbia, Spain, Romania

As the Principal Consultant you must be a nationally recognized professional in their field of expertise with welldeveloped and proven rainmaking skills. You will have a comprehensive understandingof the organization's consulting models and methodologies, as well as, an extensive knowledge of whatservices the group provides. You must have strong technical skills and specialist knowledge ofa subject matter or market. You will provide a full range of consulting services and workswithin the personal area of expertise and provide mentoring and guidance to junior teammembers on technical and/or business issues and supports knowledge-centered activities within the department.

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.)
- Functions as the main client contact and ensures accurate project reporting is in place

Thought Leadership
-
Delivers presentations at seminars and industry group meetings Authorsarticles for publication in industry agazines, newsletters, book chaptersand other forums
- May serve as a member of industry association boards, task forces andcommittees and/ or as chairperson or officer of one or more professionalassociations. Contributes expertise to professional societies, academic or
other similar groups influential in his/ her area of expertise

Consulting Activities and Relationship Management
-Applies the appropriate organization's consulting models andmethodologies and assists in the design/improvement the methodologieswhen needed
- Provides a full range of technical and/or business consulting services withinpersonal area of expertise including representing clients to regulatoryagencies
- Completes and delegates project activities in a timely manner with anunderstanding of issues which may impact project profitability and clientsatisfaction

Business Development
- Actively prospects and leverages new business opportunities with clientand industry contacts in collaboration with Account Management
- Presents information about PC service offerings reflecting theorganization's capability to support client needs
- Generates new or repeat business due to personal name recognition orhistory of client satisfaction and/or relationship

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 and project deliverable archiving.
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 aregulatory 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!Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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