Regulatory Affairs Senior Associate / Associate Manager - CTA
|Area||North London, UK|
|Sector||Pharma / Biotech|
|Salary||£ 40,000 ~ 52,000 Annual Rate|
Based at a growing organisation, working on a wide scope of products and therapy areas, this key partner of ours is looking for a Regulatory professional with strong CTA experience.
- Responsibilities:Prepare and submit Clinical Trial Authorisation (CTA) applications and substantial amendments to competent authorities throughout Europe.
- Assist with managing workload of clinical trial team and prioritisation decisions.Review and extract information from clinical trial associated documentation (incl. IMPDs, IBs, EudraCT, Protocols & labelling)
- Quality control check junior member of staff work and contribute to their training.
- ExperienceGraduate in relevant scientific discipline
- Broad Regulatory CTA experience covering a range of EU countries
- Experience in preparing submissions for both competent authority and ethics committees.
- Experience with IRAS system and HRA process for UK submissions.
- Ability to work under pressure and achieve timely submission and regulatory approvals
- Good computer skill
- Self-motivated with excellent communication skills
- Strong attention to detail
Reports to: Regulatory Affairs Senior Manager
For further information contact Natalie Hopkins on 0207 183 5059 or email firstname.lastname@example.org