Regulatory Affairs Consultant - 2 Year Contract

12 Apr 2021
06 May 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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

• 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

• 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.

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