Regulatory Affairs Manager

This job has now expired please search on the home page to find live IT Jobs.

About the Company My client is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 45+ employees. They develop and manufacture innovative patient friendly pharmaceutical products for international markets. They are now seeking an experienced Regulatory Manager as they expand and broaden our range of non-sterile oral products. The Role: The Regulatory Manager will take responsibility for leading all regulatory activities 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. Qualifications and Experience required At least 3 years of 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.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. If you'd like to discuss the chance of becoming Regulatory Manager please apply immediately with an updated CV for immediate consideration. Unsure yet? Get in touch with myself for a confidential conversation on or 0830363395. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales