See All Jobs

Engineering & Technical

Scientific & Laboratory

Job Description

A Senior Regulatory Affairs Officer is required by CareerWise Recruitment for our West Dublin based multinational pharma client. The Snr Regulatory Affairs Officer will play a leading role in an expanding Reg Affairs Department with an extensive range of products and a rich pipeline of new products coming on line. This is a full time permanent position with excellent benefits.

Role of this position

  • Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals
  • Develop professional working relationships with assessors and administrative staff within the regulatory agencies
  • Prepare high quality regulatory applications and regulatory responses (including inputting into summary documents and responses for European applications)
  • Defend existing labelling and provide regulatory input into patent defence strategies
  • Ensure timely submission and approvals of licence applications and maintenance activities and compliance with regulatory requirements
  • Assure appropriate standards and policies for all technical aspects of the company's activities in Regulatory Affairs are adhered to
  • Actively contribute to cross-functional team working and other areas of the business
  • Deliver the commercial objectives, including representing Regulatory Affairs on teams as appropriate
  • Understand and promote Irish business needs into European strategies on drug development and regulatory filings/issues
  • Ensure appropriate cross functional input into the delivery of optimal licence strategies
  • Proactively identify regulatory strategies to support commercial and business objectives and company efficiencies.
  • Keep up-to-date with developments in the Regulatory Environment and share this knowledge across the department and beyond, in the business interest

JOB REQUIREMENTS

  • Degree qualified in Life Sciences, pharmacy or related discipline
  • Previous 4-5 years' experience in pharmaceutical regulatory affairs

Please call Michael Hanrahan today for further information on 021-2019817 or email: mhanrahan@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

Apply Now

Engineering & Technical

Scientific & Laboratory

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie