Regulatory Affairs Associate

Employer
Regulatory Professionals
Location
Central London / West End
Closing date
9 Oct 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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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*

Every member of our team is committed to delivering the highest level of service. This translates to offering consistent and exceptional service to each and every candidate we work with. Working in cooperation and partnership our aim is to build trust through consistent delivery, to keep our promises and to exceed expectations.

Our teams are experts in their pharmaceutical markets, both geographically and technically. As we fully understand each of the pharmaceutical sectors we work within, we can be flexible in our approach to matching candidate expectations, finding the right position in the best location. With coverage across nine European Markets via our Multilingual International hub in central London we can offer expert technical knowledge with local understanding.

 

 

Contact Us
  • 33 Blagrave Street
  • Reading
  • RG1 1PW
  • GB
  • +44 (0)118 9522 797
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