About Xeolas

Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 60+ employees. We develop and manufacture innovative patient friendly pharmauceutical products for international markets. We are now seeking an experienced Regulatory Affairs Manager as we expand and broaden our range of non-sterile oral products.

Overall Role Objective

The Regulatory Affairs Manager will take responsibility for leading all regulatory activities.

Specific Responsibilities:

• Responsible for supporting the strategic development of global submissions, including those required in the EU, US and ROW.
• Responsible for executing all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific policies and procedures.
• Prepare and / review submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs and external partner Regulatory Leads.
• Demonstrate capability to develop and execute upon regulatory strategy and of answering regulatory questions from Regulatory Authorities.
• Maintain knowledge of regulatory requirements and communicates changes in regulatory information to project teams.
• Represent Regulatory at internal meetings and in conjunction with the Technical Director, at meetings with regulatory authorities.
• Contributes to local process improvements which have a significant impact on the business.

Key Skills / Experience Requirements:

• At least 5 years of relevant experience in Pharmaceutical Regulatory Affairs / Quality or other relevant industry experience with relevant Bachelor Degree including hands-on CMC experience (initial registrations / post-approval variations)
• Sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP's required to assess technical, scientific and regulatory merits of CMC information, commitments and data.
• Experience with regulatory requirements and expectations, criteria for submission and approval and experience of interactions with regulatory authorities for projects.
• Updating, interpreting, and applying global ICH / CMC guidelines, along with the ability to contribute to global regulatory strategies.
• Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, influence and lead.
• Excellent critical thinking and problem-solving abilities.
• Excellent Project Management Skills.
• Experience in Pharmacovigilance is desirable but not essential.