Skip to main content

This job has expired

Regulatory Affairs Consultant - 2 Year Contract

Employer
Parexel
Location
Poland
Salary
Competitive
Start date
3 Feb 2021
Closing date
5 Mar 2021

View more

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

Job Details

Job Description

We are recruiting for a Regulatory Affairs Consultant to join our Clinical Trial Regulatory Services EU Consulting teamin Poland .This is an ideal role for a Regulatory Leader who would excel working in a fast-paced international team. This is a 2 year contract initially.

German language skills are highly desirable but not essential for this role.


You will be responsible for:
- Acting as a local regulatory Lead for clinical trials in Poland and other european countries, you will be responsible for preparation and quality control of local regulatory submission packages for submissions to RAs to ensure regulatory compliance, accuracy and completeness.
- Acting as a regulatory lead managing the regulatory submission strategy and process worldwide throughout entire project life cycle, ensures global regulatory compliance and cross-functional communication.
- Providing regulatory consultancy and support for establishing the submission strategy for clinical trial application, response management, amendments and other maintenance submissions. Interacting with regulatory authorities, as required; liaise with internal and external partners on assigned projects.
- Preparation, review and approval of labels.
- Mentoring junior/new colleagues.Qualifications

Skills:
• Regulatory Project management knowledge
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Client-focused approach to work (Quality)
• Results orientation
• Teamwork and collaboration skills
• Consulting skills
• Critical thinking and problem-solving skills
• Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:
• Several years of experience in an industry-related environment

Education:
• Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree PreferredWhy 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

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert