Senior Regulatory Affairs Associate - CTA
- Employer
- Parexel
- Location
- Warsaw, Poland
- Salary
- Competitive
- Start date
- 13 Apr 2021
- Closing date
- 13 May 2021
View more
- Discipline
- Clinical Research
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
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
Education:
- 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.
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.
- Website
- http://www.parexel.com/
- Telephone
- +44 1895 238000
- Location
-
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB
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