
Regulatory Strategy Specialist
4 days ago
The Regulatory Affairs Manager CMC will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulatory requirements.
Key responsibilities include:
- Developing robust regulatory strategies to mitigate risks
- Preparing and delivering high-quality CMC regulatory submissions and submission management plans for global regulatory agencies
- Executing regulatory policies and operational processes for delivering the product portfolio
The ideal candidate will have hands-on experience in CMC authoring, sufficient knowledge of current Good Manufacturing Practices (cGMPs), and technical, functional, and industry knowledge to shape strategic direction of assigned projects.
-
Global Regulatory Strategy Lead
4 days ago
Dublin, Dublin City, Ireland beBeeDirector Full time €113,180 - €145,935Regulatory Affairs Director Job SummaryWe are seeking an accomplished Regulatory Affairs Director to spearhead our pharmaceutical organisation's regulatory strategy.Job Description:The successful candidate will be responsible for developing and implementing global regulatory strategies for assigned products, providing strategic oversight for projects in...
-
Regulatory Strategies Research Lead
7 days ago
Dublin, Dublin City, Ireland beBeeRegulatory Full timeRegulatory Strategies Research Lead – MedTech and Connected Health AccelerationThis role is pivotal in driving the success of a collaborative initiative to advance research commercialisation of novel healthtech innovations. We seek an experienced professional with a deep understanding of medtech and connected health regulatory landscapes and associated...
-
Specialist Regulatory Response Professional
2 days ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €120,000Regulatory Response Specialist Job DescriptionWe are seeking a skilled Regulatory Response Specialist to join our team. The ideal candidate will be responsible for reviewing and analyzing regulatory proposals, developing and implementing effective response strategies in consultation with stakeholders, and providing expert advice to senior management on...
-
Data Strategy Associate Director
3 days ago
Dublin, Dublin City, Ireland PLACE Strategy GmbH Full timeWhen you join KPMG Ireland, you are joining a community of over 4,200 employees who collectively work together, both in person and virtually, to achieve their full potential.We are known as an organisation that encourages you to come as you are and do work that truly matters. Joining KPMG Ireland is an opportunity to enhance your career, not only through the...
-
Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €100,000Job Title: Associate Director Regulatory AffairsThe position of Associate Director Regulatory Affairs involves overseeing the development and implementation of global regulatory strategies for assigned products. This role requires expertise in drug development and regulatory policy, as well as strong scientific and business judgment.About the RoleThis...
-
Data Strategy Associate Director
2 weeks ago
Dublin, Dublin City, Ireland PLACE Strategy GmbH Full timeWhen you join KPMG Ireland, you are joining a community of over 4,200 employees who collectively work together, both in person and virtually, to achieve their full potential.We are known as an organisation that encourages you to come as you are and do work that truly matters. Joining KPMG Ireland is an opportunity to enhance your career, not only through the...
-
Senior Regulatory Affairs Specialist
1 day ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €60,000 - €80,000Job Title: Senior Regulatory Affairs SpecialistThis role is perfect for someone who wants to make a real impact in the pharmaceutical industry. As a Senior Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve business goals.Job Description:Develop and implement...
-
Regulatory Affairs IT Specialist
3 days ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €120,000Regulatory Affairs IT SpecialistWe're looking for a skilled Regulatory Affairs IT Specialist to join our team. This role involves overseeing the development and implementation of IT solutions that support regulatory compliance across various industries, including pharmaceutical manufacturing, hospitals and healthcare, and biotechnology research.About The...
-
Dublin, Dublin City, Ireland PLACE Strategy GmbH Full timeWhen you join KPMG Ireland, you are joining a community of over 4,200 employees who collectively work together, both in person and virtually, to achieve their full potential.We are known as an organisation that encourages you to come as you are and do work that truly matters. Joining KPMG Ireland is an opportunity to enhance your career, not only through the...
-
Regulatory Compliance Specialist
5 days ago
Dublin, Dublin City, Ireland beBeeCompliance Full time €90,000 - €120,000Regulatory Compliance Specialist RoleThe primary objective of this position is to ensure adherence to regulatory requirements and industry standards. The role encompasses the implementation, enhancement, and ongoing evaluation of compliance processes.Main Responsibilities:Develop and execute strategies to maintain awareness of emerging regulatory changes and...