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Senior Affairs Associate (Clinical writer)

Bucharest, București, Romania Date posted 09/20/2021 Job ID 74476BR

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.

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

A Regulatory Affairs Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting provides. A Regulatory Affairs Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Regulatory Affairs Consultant assures the work of the entire team is delivered on time and that it meets client’s quality expectations.

We are currently looking for a Regulatory Affairs Consultant who will have the following responsibilities:
  • Regulatory Delivery Experience in LCM (Clinical and Labelling)
  • Strong understanding of regulatory labelling (and clinical) lifecycle maintenance activities across EU and ROW markets
  • Change Control assessment experience or transferrable skills (application of relevant regulatory guidance to proposed change)
  • Needs experience in: PSUR updates, management of CCDS updates and submission experience of simple and complex labelling variations to EU markets
  • Capable of participating in discussion on regulatory strategies with a wide stakeholder network (Global Labelling, Supply, Brand Leads etc.) with support of an SME
  • ‘Proactive’ and ‘efficient working method
  • Able to adhere to internal and HA timelines

Qualifications

Ideal candidate will possess:
  • Good understanding of performing the above regulatory tasks on a global level
  • Several years of MAA and Lifecycle Maintenance experience for EU and APAC/LATAM
  • Change control assessment experience for EU
  • Very good project management skills
  • Proactive approach and excellent communication skills
  • Fluent English
  • University degree

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