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Senior Regulatory Affairs Associate (MAA & CTA)

Prague, Hlavní město Praha, Czechia Date posted 11/26/2019 Job ID 56704BR

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

  • Full Time
  • Level: Mid
  • Travel: Yes
  • Glassdoor Rating 3.5

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "They say if you are passionate about what you do, you will never work a day in your life. I can honestly say that this applies to me. I love what I do."

    Jasen - Consultant
  • "My experience so far with Parexel has been great! I had initially started at Parexel as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."

    Aqip – Consultant
  • "I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. Parexel is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."

    Blaine – Consultant
  • "Parexel is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), Parexel offers a variety of rewards to the employees (bonus scheme, benefits etc)."

    Giannis – Consultant
  • "Parexel is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."

    Aqip – Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

Parexel are looking for a Senior Regulatory Affairs Associate (CTA & MAA) to be based in Czech Republic, in our Prague Office. You will be joining a highly experienced and friendly team of 10 regulatory professionals.

Key Responsibilities
  • Acting as a local regulatory contact representing various MAHs in Slovakia and/or Czech Republic, especially covering MAs related maintenance activities.
  • Acting as a local regulatory contact for clinical trials in the Czech Republic, Slovakia and Canada, including preparation and quality control of local regulatory submission packages for submissions to RAs 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. Preparation, review and approval of labels.
  • 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.
  • Mentoring junior/new colleagues.

Qualifications

Ideal candidate will possess
  • Education: Minimum of a Bachelor’s Degree in a Scientific Discipline, Advanced Degree Preferred.
  • Minimum Work Experience: At least 2 years’ experience in a Regulatory affairs environment (CRO/Pharma)
  • Language Skills: Slovak/Czech, fluent vocal and written English
  • Excellent computer skills (MS Office)
  • Excellent Communication Skills
  • Proactive approach
  • Client-focused approach to work
  • Teamwork and collaboration skills
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 base salary and benefits package including 25 days holiday per year, a strong contributory pension scheme, daily meal vouchers and many more flexible benefits for you to select.

Apply today to begin your Parexel journey!

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