Regulatory Submissions Analyst

Location
Buckinghamshire
Salary
Competitive FTC rate of pay
Posted
07 Sep 2021
Closes
24 Sep 2021
Ref
0709RSA
Discipline
HEOR, Analyst
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

DETAILS:

  • Full-time contract position
  • ASAP start for minimum 6 month contract
  • Office + homebased in the UK
  • Competitive FTC rate of pay
  • Global pharma company

 

THE ROLE:

  • Supports Regulatory Information Management (RIM) activities within the International region focusing on key systems and processes, including the BRIDGE (RIM system), archiving systems, the Artwork Management System (The Hub)
  • Works with other members of International Regulatory Affairs to ensure that submissions and approvals are tracked and archived in accordance with local and global SOPs.
  • Builds and maintains relationships with Regulatory and other staff within and outside of the region to ensure effective communication and efficient implementation of regulatory information management

BRIDGE (Regulatory Information Management System) 30%                                                                                                       

  • Establish relationships with ‘in-country’ teams and global regulatory teams to ensure that they are aware of how Regulatory Information is managed.
  • Work with other Local System Administrators to suggest, discuss and implement system and process improvements in line with regulatory changes and as part of a quality management cycle, subject to Global Data Council representations and approvals. 
  • Work with global RD-IT to implement system upgrades and other improvements, including system testing and user training as needed.
  • Maintain compliance with departmental SOPs and Work Instructions.

Artwork Management System (The Hub) 25%

 

  • Create project trackers within the Hub to ensure that Regulatory Affairs are able to distribute notifications relating to regulatory submissions and approvals
  • Align information within the project trackers and the BRIDGE system
  • Ensure there is a mechanism for feedback from colleagues, customers and system owners to ensure system and process remain efficient, implementing improvements as and when required.

European Invoice Coding 10%

 

  • Understanding and adherence with tracking of all financial invoicing and Approvals, to ensure key finance information is implemented in the correct manner and within the due date specified. (Training will be provided) 

Archiving 30%

  • Ensure understanding and adherence with regional SOPs to ensure that all regulatory submissions, approvals, commitments and agency questions are archived accurately

Training 5%

  • Contributes towards presentations and training sessions (for all systems and processes) as and when required.

Full job description available on application

 

THE CANDIDATE:

  • Graduate (preferably in a Life Science or IT related discipline), or equivalent/relevant experience.
  • Knowledge of Regulatory Business Processes / Pharma R&D Business
  • Some knowledge of European Regulatory Procedures (Centralised, Decentralised and Mutual Recognition)
  • Some knowledge of Regulatory Submission types (MAAs, Variations, Renewals, CTAs, DSURs etc)
  • Ability to identify compliance risks and escalate when necessary
  • Ability to multitask, prioritize, and manage multiple projects and deadlines
  • Only candidates with existing right to work in the UK/EU will be considered

 

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.