Senior Regulatory Affairs Associate - CTA

Warsaw, Poland
25 May 2021
24 Jun 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

We are recruiting for a Senior Regulatory AffairsAssociate in Poland with extensive CTA and local Polish submissions experience.

You will be responsible for:

• Supports Project Management in executing regulatory part of the project
• Preparation and review of drug labels to ensure compliance with GMP Annex 13
• Preparation of initial clinical trials registration dossier, substantial and non-substantial submissions of clinical trial to Polish Regulatory Authority according to the Polish regulatory requirements.
• Expertise of legal documents required for submissions as well as provides reviews of documentation and indicates deficiencies.
• Advises Sponsors to classify the various type of submissions per local requirements showing the urgent amendments to be deemed necessary.
• Communication with Polish Regulatory Authority
• Providing internal Quality Check of submission packages.
• Archiving regulatory documentation.Qualifications

Experience Required:
- Project management knowledge
- Client-focused approach to work
- Results orientation
- Teamwork and collaboration skills
- Minimum of 2 -3 years experience within a regulatory submissions role
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Critical thinking and problem-solving skills
- Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:
- 3-5 years of experience in an industry-related environment

- Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

If this sounds like you, we encourage you to apply! You will be rewarded with a competitive salary and benefits package!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.

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