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Job Title
Senior Regulatory Affairs Consultant
Company
PAREXEL International Corporation
Job Description
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Parexel.com
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Senior Regulatory Affairs Consultant
Romania - Any Region - Home Based
Date posted
04/06/2022
Job ID
80621BR
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Overview
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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
Travel: Yes
Glassdoor Reviews and Company Rating
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
"When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."
Chris – Associate Director, Regulatory & Access
"In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"
Riley – Regulatory Affairs 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
We are currently looking for a Senior Consultant
to join the Clinical Trial Regulatory Services EU Consulting
team based in Romania/Other EU countries. This is an ideal role for someone who would excel working in a fast-paced international team.
Key responsibilities:
• Act as Regulatory Project Leader for assigned international studies.
• To prepare and coordinate of regulatory deliverables for assigned projects including close cooperation with regulatory authorities.
• Working under the general direction of the Head of Consultants Team/Project Lead, taking responsibility for ensuring that the client work is performed and delivered on time.
• Preparing, reviewing and compiling regulatory Clinical Trial Approval applications, amendments, and end of trial notifications.
• Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, GCP, Regulatory Agency requirements and internal SOPs.
• Preparation and review of drug labels to ensure compliance with GMP Annex 13.
• Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
Qualifications
Ideal candidate will possess:
• University degree in a science discipline
• Few years of experience in Regulatory Affairs and Clinical Research in Pharma or CRO in a Coordinating position
• Experience in clinical study start-up.
• Ability to work with a multinational team, focusing on multiple issues under tight timelines.
• Good Computer and Presentation skills.
• Fluency in English is a must along with the local language.
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FAQ: Hiring during COVID-19
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Our hiring process
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Flexible Work Arrangement
In-office, home-based or a mix? What’s your preference? We value the work-life balance of our employees, and as such Parexel is offering maximum flexibility to our employees wherever possible.
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