Overview

Reference Number: JO-2009-454623
Regulatory Affairs Associate
Rate: Negotiable
Job Type: Permanent
Location: Central London / West End

Role: Regulatory Affairs Associate
Location: central London
Salary: competitive + benefits
employment: full time, permanent
Job reference:

Regulatory Professionals are collaborating with a midsize, clinical contract research organization. They provide services for Phase I-IV of drug and medical device development services including regulatory services and central laboratory services. Our client is seeking a regulatory affairs profes-sional with 2-5 years experience working in a core regulatory role dealing with EMA, PIPs, Scien-tific advice and CTAs.

Other duties will include:

Preparation and delivery of regulatory submissions to domestic and international regulatory agencies;
Perform document quality control checks in accordance with established processes;
Maintain timelines for components of regulatory deliverables;
Provide day-to-day department support activities as necessary to aide completion of project deliverables;
Maintain and train on up-to-date regulatory requirements, guidance and science; and
May be responsible for other projects and responsibilities as assigned.

Knowledge & Skills
Right to work in the UK
Bachelor’s Degree in a related field; advanced degree highly preferred (M.D., Pharm.D, Ph.D.);
Good Regulatory Affairs experience in the Biotechnology, Pharmaceutical or CRO industries is essential;
Experience of the EMA Paediatric Investigation Procedure and Investigational Brochure would be an advantage;
Knowledge of EU procedure, ODD and Scientific Advice;
Experience working directly with domestic regulatory agencies;
Knowledge of and familiarity with the regulations and practices of EU regulatory agencies;
Excellent analytical, written and oral communication skills; and
Strong computer skills and project managements skills, and a high attention to detail; and
Must be a team player.

If you would like to apply for this position, please contact Amani via amani@regulatoryprofessionals.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*