Senior Manager, Regulatory Intelligence
4 months ago
This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization. This position will also serve as a lead Reg Intel contact in support of cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organization’s GxP framework.
In this role, a typical day might include:
Project Management and leadership in the delivery of regulatory intelligence research services and information
Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders
Managing more complex intelligence query requests from internal stakeholders
Serving as the functional lead on cross-functional organizational level projects or initiatives in supporting of GxP compliance or requirements
This role might be for you if can:
Monitor and analyze the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders
Monitor and analyze global regulatory intelligence sources for the most current changes and information in the drug development space
Assess regulatory intelligence information for relevance and impact to company’s internal processes, drug development projects and/or regulatory strategies
Identify business critical aspects and communicate effectively to internal stakeholders
Support project teams, functions and departments through the collection and distribution of requested regulatory intelligence information.
Provide regulatory intelligence in support of a range of operational study design and operational planning activities. This includes regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input into feasibility.
To be considered for this opportunity, you must have the following:
Advanced life science degree or related field
Minimum of 7 years experience in the biotech/pharmaceutical industry with a strong focus in Regulatory Intelligence
Good understanding of the drug development and commercialization process, with a focus on clinical development and trial execution
Experienced in understanding and interpreting regulatory guidelines and documents
Ability to research, analyze and extrapolate critical regulatory information, with a focus on clinical requirements and recommendations
Please note, this role requires you to work 3 days onsite weekly out of our New York or New Jersey offices. If you are not local and qualify, we can offer a relocation package
#GDRAJobs #GDPSJobs
-
Manager, Regulatory Intelligence
4 months ago
Dublin, Ireland Regeneron Pharmaceuticals, Inc Full timeRegeneron is seeking a Manager to join the Regulatory Intelligence Group! In this role, a typical day might include: The Regulatory Intelligence Manager performs proactive global monitoring and surveillance of changes in the regulatory landscape focused on the drug development lifecycle, i.e., preclinical through commercialization, as well as...
-
Regulatory Intelligence Specialist
1 month ago
Dublin, Ireland Parexel Full timeWhen our values align, there's no limit to what we can achieve. We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team. As a Regulatory Intelligence Specialist , you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and...
-
Intelligence Senior Analyst
5 months ago
Dublin, Ireland 02623 Citibank Europe plc Full timeAre you looking for a career move that will put you at the heart of a global financial institution? Then bring your skills in analysis, problem solving and communication to Citi bank. By Joining Citi, you will become part of a global organisation whose mission is to serve as a trusted partner to our clients by responsibly providing financial services that...
-
Senior Manager
1 month ago
Dublin, Ireland Permanent TSB Full timePTSB is one of Ireland's leading retail and SME banks, with an innovative range of products and services powered through an evolving digital landscape, our focus is centred on ensuring we deliver what our customers, colleagues and communities need to be successful. ** Your Role: The Senior Manager - Regulatory Reporting Interpretation will lead a team...
-
Senior Business Intelligence Analyst
2 months ago
Dublin, Ireland Reperio Human Capital Full timeJob Title: Senior BI Analyst Location: Dublin Salary: €(phone number removed)HybridReperio are working with a multi-national company in the sports industry who are seeking a skilled Senior BI Analyst to join their Insights and Data team here in Ireland. The successful candidate will work closely with key stakeholders to understand business needs, gather...
-
Threat Intelligence Analyst
6 months ago
Dublin, Ireland Microsoft Full timeOverview Security represents the most critical priorities for our customers in a world awash in digital threats, regulatory scrutiny, and estate complexity. Microsoft Security aspires to make the world a safer place for all. We want to reshape security and empower every user, customer, and developer with a security cloud that protects them with end...
-
Senior Regulatory Affairs Assistant
4 months ago
Dublin, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
-
Senior Regulatory Affairs Manager
2 months ago
Dublin, Ireland Parexel Full timeWhen our values align, there's no limit to what we can achieve. We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies...
-
Dublin, Ireland ICON Clinical Research Limited Full timeVP, Global Regulatory Affairs Consulting Services/ Ireland ,UK, Spain, Poland / Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. This is an...
-
Program Manager, Regulatory Compliance
4 months ago
Dublin, Ireland TikTok Full timeAbout the team : Our Trust & Safety team's commitment is to keep our online community safe. We have invested heavily in human and machine-based moderation to remove harmful content quickly and often before it reaches our general community.As our international organization expands rapidly and becomes more complex, so too does the regulatory and legal...
-
BSA – Business Intelligence Enablement
1 month ago
Dublin, Ireland TD Global Finance Unlimited Company Full timeDescription : Job Title: BSA – Business Intelligence Enablement Job Level: L10 Job Type: Non Regulated Business/Product Group: Technology Location: Dublin, Ireland Committee Membership: n/a Direct Reports: n/a Business context TDS Data Platform is a self-service data platform for TD Securities offering all data management...
-
Strategic Intelligence Analyst
6 months ago
Dublin, Ireland CRH Full timeCountry: Ireland City: Dublin Req ID: 496826 About CRH We are CRH, and we are committed to contributing to a more resilient and sustainable built environment. We understand the wider impact our businesses can make in supporting human activity. We continue to do this through the delivery of unique, superior building materials and products...
-
Finance Prudential Regulatory Senior Associate
4 months ago
Dublin, Ireland Davy Group Full timeAbout us From day one, you’ll notice there is something special about working at Davy. Our success is built on nearly 100 years of forging strong relationships with our clients and developing the careers of Ireland’s future business leaders. Established in 1926, the Davy Group sits at the heart of wealth and capital in Ireland, providing a broad range...
-
Threat Intelligence Analyst
4 months ago
Dublin, Ireland Pinkerton Full timeJob Summary: The Threat Intelligence Analyst, assigned to one of Pinkerton's largest global clients, will investigate, interprets, and communicates information from a variety of sources to identify and assess inappropriate communications and threats directed toward high-value people and assets to mitigate potential targeted acts of violence. The...
-
Senior Business Analyst
2 months ago
Dublin, Ireland NTT DATA Services Full timeNTT DATA Services strives to hire exceptional, innovative, and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now SummaryWe are seeking a knowledgeable and experienced Senior Business Analyst with extensive IT/Consulting experience in the financial services...
-
Senior Business Analyst
3 weeks ago
Dublin, Ireland NTT DATA Full timeJob Description NTT DATA Services strives to hire exceptional, innovative, and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply nowSummaryWe are seeking a knowledgeable and experienced Senior Business Analyst with extensive IT/Consulting experience in the financial...
-
Business Intelligence
2 months ago
Dublin, Ireland Abbott Full timeAbbott Ireland Financial Services Cherrywood Dublin Abbott’s EMEA Finance Shared Services centre commenced operations in Cherrywood, Dublin in October 2015. From this location the Finance Shared Services provides processing and expertise, in local languages, to Abbott divisions and affiliate companies across EMEA. The core services are in Record to...
-
Senior Legal Counsel ESG
2 days ago
Dublin, Ireland Primark Full timeJob Description Because we strive to put people first. Culture, our way. What’s a career at Primark all about? The positive impact you’re making, the experiences you’re having and the people you’re with. You’re our inspiration. Embrace...
-
Senior Actuary, Reinsurance
3 months ago
Dublin, Ireland AXA Group Full timeSenior Actuary, Reinsurance London / Dublin We are looking to recruit a senior actuary to join a team of experienced actuaries to lead the regulatory reporting and submissions for the Reinsurance Business Group at AXA XL. DISCOVER your opportunity What will your essential responsibilities include? Reporting to the Reinsurance Chief Actuary and...
-
Manager, Regulatory Affairs CMC
4 months ago
Dublin, Ireland Regeneron Pharmaceuticals, Inc Full timeWe expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. In this role, a typical day might include the following: Contributes to the management of the regulatory submission form process,...