Senior Regulatory Affairs Officer - Compliance

Location
Dublin (County), Leinster (IE)
Salary
Negotiable depending on experience
Posted
25 Feb 2021
Closes
27 Mar 2021
Ref
ZHJO-2101-461595
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

On behalf of our client, a leading global pharmaceutical company, we are currently recruiting for a Senior Regulatory Officer Submissions. This is a permanent, full-time role.

Main Objective of Role

  • All general RA activities as per RA Officer Compliance job specification e.g.:
  • Manage new applications, variations and maintenance of International MA’s
  • Gap analysis and remediation of International CMC documentation
  • Build and develop International regulatory strategy and regulatory intelligence
  • Collaboration with stakeholders to support active MA’s and related activities
  • In addition to items outlined below
  • Lead by example in completing tasks and interacting with colleagues and stakeholders
  • Team mentoring and training
  • Continuous development awareness

Other activities as assigned by Team Leader / Manager / Head

Job Duties

SENIOR  OFFICER EXPECTATIONS

  • Lead project teams or working groups as directed by management
  • Provide mentoring and support for new starters and less experienced team members
  • Representing RA Compliance at relevant meetings / telecons / WebExs
  • Lead by example to ensure tasks are completed in a timely and effective manner
  • Lead by example by displaying ownership and taking accountability for assigned activities
  • Proactive identification and reporting of potential issues to management
  • Ongoing process and systems assessment to enable continuous development
  • Develop / deliver training as appropriate
  • Contribute to the development and implementation of RA policies, processes, SOPs and other

 

DOSSIER MANAGEMENT

  • As per RA Officer Compliance job specification
  • Peer review of dossier documents for accuracy, completeness and compliance
  • Oversee dossier build timelines for any assigned team projects
  • Timely escalation of issues causing delays with dossier development

REGISTRATION PROCESS

  • Assist RO’s with managing risks and evolving timelines, and with remediation of issues

PERSONAL DEVELOPMENT

  • Identify and communicate perceived key strengths to management in order to work more effectively and assist manager with smart project planning

Minimum Skills / Experience:

  • Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
  • Minimum 3 years experience in a regulatory affairs environment
  • Relevant experience in, and general knowledge of, the pharmaceutical industry
  • Knowledge of EU and other regions current registration and dossier  requirements
  • Knowledge and ability to source International registration requirement information
  • Excellent computer competency e.g. Word, Excel, Access, Powerpoint etc
  • Experience with systems and tools specific for RA and pharmaceutical sector

For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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