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Senior Regulatory Officer - Compliance

Ref: 9217842

  • €50,000 - €55,000
  • 17 Jun 2019
  • Dublin (West)
  • Perm

Brightwater has been retained in the search for a Senior Regulatory Officer – Compliance to work with all general RA activities as per RA Officer Compliance job specifications.

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 • Perform assigned work according to good regulatory practice and in compliance with current legislation and regulatory guidelines

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

• As per RA Officer Compliance job specification • Assist RO’s with managing risks and evolving timelines, and with remediation of issues

Personal Development:

• As per RA Officer Compliance job specification • Identify and communicate perceived key strengths to management in order to work more effectively and assist manager with smart project planning • Identify and communicate perceived areas for improvement to enable development of effective Personal Development Plans and Group Training schedules

Person Profile:

• Results and performance driven – deliver results that meet or exceed expectations • Ability to lead and support several concurrent projects/products with strong multi-tasking abilities • Develop productive relationships within cross-functional teams • Ability to prioritise decisions and address critical issues impacting the business • International Able to cope with evolving deadlines effectively • Possess cultural awareness and sensitivity

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 To apply for this Senior Regulatory Officer – Compliance role, click the “Apply Now” button or for more information, please contact Marc Bentley on 01 662 1000 or email m.bentley@brightwater.ie