Senior Regulatory Affairs Associate - CMC

1 day left

United Kingdom
09 Apr 2021
09 May 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

We are recruiting for a Senior Regulatory Affairs Associate - CMC to support one of our pharmaceutical client partnerships. This is a homebased opportunity in the UK. Ideally we are looking for2-3+ years CMC Regulatory Delivery Experience in Lifecycle Maintenance (LCM)

You will be responsible for:
  • Good understanding of CMC LCM activities across EU and Rest Of World (ROW) markets
  • Change Control assessment experience (need to understand how to apply relevant regulatory guidance to proposed changes)
  • CMC Submission experience of Simple (Type I) and complex variations (Type II) to EU markets in the Centralised Procedure (CP), Mutual Recognition Procedure (MRP) and National Procedures (NP). Experience working on simple and complex LATAM (Latin America) and APAC (Asia-Pacific) region submissions would be of benefit.
  • Capable of participating in discussion on regulatory strategies with a wide stakeholder network (Quality Assurance, Brand Leads etc.) with support of an Subject Matter Expert (SME)
  • 'Proactive' and 'efficient' working method
  • Strict adherence to timelines (both internal and Health Authority deadlines)
  • Qualifications

    - Project management knowledge
    - Client-focused approach to work, supporting 1 client relationship
    - Results orientation
    - Teamwork and collaboration skills
    - Excellent interpersonal and intercultural communication skills, both written and verbal
    - Critical thinking and problem-solving skills
    - Proficiency in local language and extensive working knowledge of the English language

    Knowledge and Experience:
    - Few years of experience in an industry-related environment

    - Minimum of a Bachelor's Degree in a Scientific or Technical Discipline

    If you feel you have suitable experience we encourage you to apply, you will be rewarded with a competitive salary and benefits package!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.

    Similar jobs

    Similar jobs