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Senior Regulatory Affairs Officer - Compliance

Employer
Thornshaw Recruitment
Location
Dublin (County), Leinster (IE)
Salary
Negotiable depending on experience
Start date
26 Jan 2021
Closing date
25 Feb 2021

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

Job Details

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

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

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For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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