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Regulatory Affairs Consultant (Veterinary Medicinal products)

Employer
Parexel
Location
Romania
Salary
Competitive
Start date
23 May 2022
Closing date
1 Jun 2022

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Job Description

We are currently looking for a Regulatory Affairs Sr. Associate/Consultant (Veterinary vaccines) who will have the following responsibilities:
  • Regulatory assessment of change control requests (mainly CMC) in change control system and under consideration of all relevant SOPs and with respect to regulatory compliance (e.g. variations).
  • Collaborate with Global RA CMC lead and/or Regional RA CMC lead to provide regulatory support for assigned projects
  • Initiation and co-ordination of quality (CMC) documents preparation for required regulatory activities to ensure regulatory requirements.
  • Review and assessment of the above-mentioned quality documents under regulatory aspects (regulatory compliance, requirements of European competent authorities for veterinary medicine).
  • Compilation of submission documentation (data packages/dossiers) for handover to the publishing team.
  • Review and assessment of the submission documentation following publishing (and before submission to competent authorities) regarding completeness as per template and accuracy.
  • Response to deficiency letters and authority request in due form (template) and time



    • Qualifications

    The deal candidate will possess:
  • BSc Degree in veterinary medicine or advanced degree
  • At least 3-5 years of pharma/biopharmaceutical regulatory experience
  • Good understanding of CMC lifecycle maintenance activities across EU (and US - it would be a plus)
  • Change Control assessment experience (application of relevant regulatory guidance to proposed change)
  • CMC Submission experience of Simple (Type I) and complex variations (Type II) to EU markets in the CP, MRP and NP procedures.
  • Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME
  • Able to adhere to internal and HA timelines
  • Strong problem solving and diplomacy skills
  • Exposure to regulatory requirements for biologic product development is highly desired
  • Good project management skills
  • English advanced level


    • 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

    When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

    How to describe Parexel’s culture in one word: 

    Henry

     

     

    Working With Heart™ - Christina's perspective:

    Working With Heart™ - Christina's perspective:

     

    Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

    Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
     Uxbridge
    Middx
    UB8 1LZ
    United Kingdom
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