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Regulatory Operations Specialist

Employer
Planet Pharma Staffing Limited
Location
Slough, UK
Salary
Competitive Hourly Rate
Start date
28 Feb 2019
Closing date
30 Mar 2019

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Job Details

MAIN RESPONSIBILITIES

1. Support Global Regulatory Operations Leads in the coordination, preparation, and submission of all INDS/NDAs/MAAs & 510Ks and life cycle management in eCTD as well as paper and NeeS formats.

2. Responsible for the creation, assembly, publishing, and verification of both major and routine regulatory dossier submissions, including IND safety reports, DSUR, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Responses, etc.

3. Responsible for maintenance of all Regulatory and Health Authority submission archiving within specified time frames.

4. Verification of regulated electronic documents via workflows within companies electronic document management system.

5. Adherence to required submission timelines, health authority publishing specifications, and internal working practices.

6. Liaise with functional source areas (clinical, nonclinical, cmc, regulatory) to ensure documents are compliant with authoring style guide.
- Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
- Close interaction with authoring community to track availability of deliverables.

7. Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.




SKILLS REQUIRED

 

  • 2 yrs. pharmaceutical industry experience required (MUST specifically be in Regulatory Operations)
  • BA/BS Degree or equivalent experience
  • Demonstrated experience with compiling eCTD submissions in a publishing tool (eg, eCTDXPress, eCTDManager, ViewPoint, etc)
  • Technical knowledge of electronic publishing systems/document management systems and software
  • Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic
  • Proficiency with MS-Office Suite and Adobe Acrobat applications
  • Knowledge of health authority procedures/guidance’s regarding electronic submissions
  • Ability to balance multiple tasks to meet priorities and timelines
  • Self-starter with superior time management skills, and ability to work independently or in teams
  • Strong attention to detail
     

LOCATION

Office based in West London

DURATION

6 month contract / full-time (1.0FTE) – view to converting permanently

SALARY

Attractive hourly pay rate on offer

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.

www.planet-pharma.com

TO APPLY

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)203 868 8607 or e-mail on schapple@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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