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Senior Regulatory Affairs Associate - CMC
Parexel International Corporation
Uxbridge, England, United Kingdom
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 for 2-3+ 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
Skills:
- 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
Education:
- 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!
Job posted: 2021-04-10