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Regulatory Affairs Senior Associate (Contract)

Employer
Planet Pharma Staffing Limited
Location
United Kingdom
Salary
Negotiable
Start date
24 Jan 2020
Closing date
23 Feb 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Role – Regulatory Affairs Senior Associate

Location – Berkshire, UK

Salary – Competitive (In line with skills and experience)

Type –  Contract 12 Months

Purpose

For one of Planet Pharma’s global clients we are currently looking for a Regulatory Affairs Senior Associate to work on a Contract basis.  


Key responsibilities include:
• Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. core CTA/IMPD development and submission)
• Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
• Coordinate collection of functional documents in support of regulatory applications
• Prepare regulatory packages and cross-reference letters to support investigator sponsored studies
• Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies

Key Skills include:

• Understanding of drug development process

About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. 

  • Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
  • We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
  •  

To apply 
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)20 3928 8384  or email me on aaitken@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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