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Senior / Regulatory Affairs Associate - CTA

Employer
Parexel
Location
Czech Republic
Salary
Competitive
Start date
26 Nov 2021
Closing date
26 Dec 2021

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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 Prague or you can be fully home based anywhere in Czech Republic. The office is open planned, and you will be working in an innovative and collaborative environment connecting with colleagues from around the world.

This role can be either Regulatory Affairs Associate or Senior Regulatory Affairs Associate depending on the level of experience you have.

As the Senior / Regulatory Affairs Associate you will develop an understanding of the organization's basic consulting models andmethodologies, as well as basic knowledge of what services Parexel provides. You must betechnically competent and continually developing the skills as defined in the key accountabilities section ofthis document. you will work under the general direction of a Project Lead and/or Technical SME,take responsibility for ensuring that client work is performed, and delivered on time, meeting the qualityexpectations of the department and the client.

Senior / Regulatory Affairs Associate
- Acting as a local regulatory contact representing various MAH's in Slovakia and/or Czech Republic, esp. covering all MA's related maintenance activities
- acting as a local regulatory contact for clinical trials in the Czech Republic, Slovakia and Canada
- Preparation and quality control of core regulatory submission packages, preparation and quality control of local regulatory submission packages for submissions to RA's in the Czech Republic, Slovakia and Canada to ensure regulatory compliance, accuracy and completeness.
-Providing regulatory consultancy and support for establishing the submission strategy for clinical trial application, response management, amendments and other maintenance submissions.
- Interacting with Czech, Slovak and Canadian regulatory authorities, as required; liaise with internal and external partners on assigned projects, provide internal and external regulatory consultancy.
- Preparation, review and approval of labels. Later when he/she get more experience/familiar with our processes to act as RL or RAL coordinating the CTA and/or MAA.
- Global Regulatory Lead for clinical trial applications coordinating regulatory activities on international multi-center trials (design, plan and schedule activities and deliverables; interact with client and project team), support and development of submission plans and strategy to regulatory authorities, oversight and support for response management. And mentor junior colleagues and performing trainings and support for submissions in the 3 countries.Qualifications

Education:
- Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree 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
- Networking
- Business analysis
- Self-confidence and control

Knowledge and Experience:
- Ideally, you will be fluent in Czech or Slovak language skills
- You will have previous experience in regulatory affairs - CTA and/or MAA submissions
- University education in the Life Sciences (Biochemistry, Biotechnology, Pharmacist) or Nursing
- Good experience in an industry-related environment; experience with a regulatory agency is desirable
- Previous CRO / Pharma experience acting in the capacity of a Regulatory Affairs Associate or Senior Regulatory Affairs Associate
- Client-focused approach to work (Quality)

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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