Regulatory Affairs Manager, Strategic Regulatory Services

Manager Regulatory Affairs, Strategic Regulatory Services (SRS)

Location: Dublin, Ireland or Marlow, UK (flexible location)

ICON plc is a leading Clinical Research Organisation, employing over 14000 people across 97 offices in 38 countries - our mission is to help our clients to accelerate the development of drugs and devices that save lives and improve the quality of life!

We are looking for passionate, resilient, and inspiring individuals to join our Strategic Regulatory Affairs (SRS) team. SRS are a global team of regulatory strategists from pharma, CRO and agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation, CMC and quality assurance. We deliver global strategic regulatory consulting, dossier management services and GMP Quality services. As Regulatory Affairs Manager, you will work in the Strategic Regulatory Services (SRS) International team who focus on provision of strategic consulting activities outside of USA and Canada.

As the Manager Regulatory Affairs you will be a Regulatory professional with:

• Prior experience with several areas of Regulatory affairs (CTA/IND/MAA) in EU or other regions and the ability to lead internal teams and carry out regulatory activities and submissions independently
• Participate in provision of Regulatory expertise in strategic drug development , as part of the SRS team, through provision of regulatory guidance and operational support to early drug development, - agency interactions, marketing applications and post approval support
• May work as part of a regulatory or cross-functional team depending on the size and nature of assigned projects
• Take part in preparation of strategic development and submission plans.
• Contributes to ICON Regulatory Affairs through their understanding of Regulatory process and interpretation of guidelines to develop best practices
• Be involved in the regulatory affairs activities across the ICON portfolio and advisor to ICON clients (externally and Internally)
• Be a trusted partner - represent the SRS Department in business development activities and generate new business opportunities

To be successful you will need

• Bachelor's degree in Regulatory/Life Sciences or relevant work experience
• Minimum of 8-10 years of Regulatory consulting experience in Pharma, Biotech, or related industry
• Experience with EU and international Regulatory procedures and requirements (CTA/ IND /MAA as well as OD/ PIP and post marketing requirements)
• Sound knowledge of the life cycle of a drug development program