Regulatory Affairs Associate

Ref. no.: LD6568

Tags: regulatory affairs global regulatory affairs regulatory pharmaceutical Dublin global regulatory affairs executive regulatory affairs executive science Jobs

Location(s): Dublin South Dublin West Leinster

Salary range (€): Negotiable

Additional benefits:

Minimum experience required: 3 - 4 Years

Employment type: Permanent Full-time

Minimum qualification: See Description

Contact person: 01 278 4703

Contact e-mail: Linda.Dunne@thornshaw.com

Job description:

Our client currently have an excellent opportunity for a Regulatory Affairs Associate. This role is involved in assisting and undertakin all registration work necessary to meet the needs of the business in Ireland and in particular to be responsible for ensuring the local company remains in constant compliance with all local regulations and international procedures.

Responsibilities:

• Coordinate and drive to completion application submissions (MAA’s, variations, renewals etc.) negotiate with the IMB to resolve any issues to minimise delay in approval.
  
• Work collaboratively with the relevant Global teams and Country Commercial teams, as necessary to establish and implement the regulatory strategies within agreed timescales to bring competitive advantage to company brands. Communicate regulatory issues that may impact on commercial teams.
  
• Maintenance of local regulatory data bases e.g. SmPC, product labelling, medicines compendium, company intranet databases etc.
  
• Review/approve promotional material as necessary.
  
• Provide regulatory support to Global Regulatory, manufacturing sites and Supply.
  
• Project work: Work in conjunction with Global team to complete product dossier compliance reviews and submit relevant variations where necessary and drive to completion.
  
• Ensure on-going regulatory and product safety compliance of company’s existing product portfolio within the assigned Category segment(s) – submission of PSUR’s/CSDS.
  
• Assist the Regulatory Affairs Manager, Ireland, to define the company’s regulatory and medical policies, guidelines and procedures as necessary.
  
• Assist the Regulatory Affairs Manager to co-ordinate the resolution of registration issues affecting the relevant products and to provide advice and insight to the Company on regulatory and product safety issues.

Qualifications and Experience:

• University Science degree ideally in a relevant Scientific discipline
  
• Ideally, experienced in the OTC market and within an FMCG environment, or within a pharmaceutical environment, with experience managing Regulatory and / or Safety functions (3 years plus experience).
  
• Experience in biocide regulations, medical devices and cosmetics regulations desirable
  
• Broad knowledge of regulatory and healthcare systems in Ireland, preferable but not mandatory
  
• Demonstrated ability to handle competing priorities effectively.

For more information on these job opportunities please email you CV to ldunne@thornshaw.com or call Linda on 01-2784671 for further information. For a list of all our jobs please log on to our website www.thornshaw.com
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