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Regulatory Affairs Consultant (CMC)

Bucharest, București, Romania Date posted 01/10/2019 Job ID 49857BR

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

What makes a successful Consultant at PAREXEL? Check out the top traits we're looking for and see if you have the right mix.

  • Detail-oriented

    10
  • Proactive

    10
  • Relationship expertise

    10
  • Problem-solver

    9
  • Results-driven

    9
  • Time Management

    9
  • Communicator

    8
  • Independent

    8
  • Multi-tasker

    8
  • "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 values passion, global perspective and expertise and we are in the process of recruiting full time, permanent Regulatory Affairs Consultant (CMC focused) to join our PAREXEL Consulting team in Bucharest.
PAREXEL Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world.

Main responsiblities include:

• Variation/Lifecycle Maintenance compilation/submission's coordination for EU/RoW regions: e.g. Simple (Type I), complex variations (Type II) to EU markets in the CP and NP procedures, Renewals etc.
• Change Control assessment experience or transferrable skills (application of relevant regulatory guidance to proposed change)
• Participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME.
• Strict adherence to timelines (both internal and HA deadlines).

Qualifications

Key requirements:

• Good understanding of performing the above regulatory tasks on a global level.
• Several years of Variation/ Lifecycle Maintenance experience.
• Relevant CMC Regulatory expertise.
• Good project Management skills.
• Proactive approach and excellent communication skills.
• Fluent English and Romanian.

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