Senior Consultant, CMC Regulatory Affairs

05 Jan 2021
04 Feb 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

We are recruiting for a European basedEU Biologics CMC expert / writer with a biotechnology background. It is essential you have significant experience with preparation and review of CMC regulatory documents (e.g. IMPD, M3 documents, briefing books, variations) for biologics.Qualifications

Skills Required:
  • High-level consulting skills
  • Critical thinking and problem-solving skills
  • Project leadership and management knowledge
  • Excellent interpersonal and intercultural communication skills, both written and verbal
  • Client-focused approach to work
  • Results orientation
  • Teamwork and collaboration skills
  • Proficiency in local language and extensive working knowledge of the English language
  • Networking
  • Business analysis
  • Self-confidence and control

  • Knowledge and Experience:
    Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus

    Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

    You will be rewarded with a competitive salary and benefits package, plus career development opportunities!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.

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