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      • dublin city centre, international
      • permanent
      • randstad financial services
      Why Work with us? Our client is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 45+ employees. We develop and manufacture innovative patient friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Manager as we expand and broaden our range of non-sterile oral products. OVERALL ROLE OBJECTIVE The experienced Regulatory Manager will take responsibility for leading all regulatory activities. This role includes flexibility on working from home and on site working. SPECIFIC RESPONSIBILITIES Responsible for supporting the strategic development of global submissions, including those required in the EU, ROW and US.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 communicate 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 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 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. 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 SkillsExperience in Pharmacovigilance is desirable but not essentialRandstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
      Why Work with us? Our client is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 45+ employees. We develop and manufacture innovative patient friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Manager as we expand and broaden our range of non-sterile oral products. OVERALL ROLE OBJECTIVE The experienced Regulatory Manager will take responsibility for leading all regulatory activities. This role includes flexibility on working from home and on site working. SPECIFIC RESPONSIBILITIES Responsible for supporting the strategic development of global submissions, including those required in the EU, ROW and US.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 communicate 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 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 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. 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 SkillsExperience in Pharmacovigilance is desirable but not essentialRandstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003

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