Current jobs related to Global Head Of Regulatory Affairs, Pharmaceuticals - Dublin, Dublin City - The Panel
-
Dublin, Dublin City, Ireland The Panel Full timeGlobal Head of Regulatory Affairs, Pharmaceuticals Key points: Our client is keen to speak with senior regulatory affairs professionals with strong leadership skills - there are a number of direct reports into this global role International regulatory markets experience is essential Entrepreneurial, commercial and growth mindset required There will be some...
-
Associate Director Regulatory Affairs
16 hours ago
Dublin, Dublin City, Ireland PE Global Full time2 days ago Be among the first 25 applicantsDirect message the job poster from PE GlobalSenior Recruitment Consultant @ PE GlobalDescription:PE Global is currently recruiting for a Regulatory Affairs Associate Director on behalf of a leading pharma company based in Dublin South. This is an initial contract role until the end of 2025.Position Summary:The...
-
Global Regulatory Leader
1 week ago
Dublin, Dublin City, Ireland beBee Careers Full timeGlobal Regulatory Leader - PharmaceuticalsWe are seeking an experienced leader to take on the role of Global Head of Regulatory Affairs, Pharmaceuticals. This is a unique opportunity for a strategic thinker with expertise in navigating complex global regulatory landscapes.
-
Global Regulatory Affairs Leader
2 weeks ago
Dublin, Dublin City, Ireland beBee Careers Full timeJob DescriptionWe are seeking a highly skilled and experienced professional to serve as our Global Head of Regulatory Affairs. This role is responsible for overseeing the development and implementation of global regulatory strategies, ensuring compliance with local regulations, and providing leadership and guidance to cross-functional teams.
-
Pharmaceutical Regulatory Affairs Specialist
2 weeks ago
Dublin, Dublin City, Ireland beBee Careers Full timePharmaceutical Regulatory Affairs ExpertAbout This PositionThis position involves providing expert advice on EU pharmaceutical regulations and ensuring compliance with relevant laws and guidelines. The successful candidate will manage EU marketing authorisation dossiers and submissions, prepare and file EU submissions, and coordinate with European Regulatory...
-
Regulatory Affairs Manager
1 week ago
Dublin, Dublin City, Ireland beBee Careers Full timeA highly skilled Regulatory Affairs Manager is required to drive the regulatory function for our pharmaceutical organisation.Key ResponsibilitiesThis is a challenging and rewarding role that involves managing regulatory activities, ensuring GMP compliance, and supporting CMC and quality assurance operations at a manufacturing site.Lead a high-performing...
-
Pharmaceutical Regulatory Manager
1 week ago
Dublin, Dublin City, Ireland beBee Careers Full timeWe are seeking a skilled and experienced Regulatory Affairs Manager to lead our Regulatory Affairs function.This role will be responsible for overseeing day-to-day regulatory activities, providing regulatory guidance to the team, and ensuring compliance with applicable requirements for our pharmaceutical products.Main RequirementsA degree in Pharmacy, Life...
-
Regulatory Affairs Director
7 days ago
Dublin, Dublin City, Ireland beBee Careers Full timeWe are seeking a highly skilled and experienced Regulatory Affairs professional to lead our regulatory activities in Ireland.Key ResponsibilitiesTeam Leadership: Lead, develop, and manage the local Regulatory Affairs team to ensure high performance, collaboration, and compliance with training and development plans.Regulatory Operations: Plan, coordinate,...
-
Global Regulatory Affairs Manager
2 weeks ago
Dublin, Dublin City, Ireland beBee Careers Full timeTake Your Career to New Heights as a Manager of Regulatory IntelligenceAbout the JobWe are seeking a highly motivated and organized Regulatory Intelligence Manager to join our team. As a key member of our Regulatory Intelligence Group, you will play a critical role in monitoring and analyzing global regulatory changes that impact our business operations.Main...
-
Head Of Public Affairs
3 weeks ago
Dublin, Dublin City, Ireland Pe Global Full time1 day ago Be among the first 25 applicants Direct message the job poster from PE Global The Deputy Director, Head of Public Affairs and Communications is a senior leadership role responsible for developing and implementing public affairs and communications strategies aligned with statutory mandates and business objectives, that promote a positive reputation...
Global Head Of Regulatory Affairs, Pharmaceuticals
2 weeks ago
Global Head of Regulatory Affairs, Pharmaceuticals Key points: Our client is keen to speak with senior regulatory affairs professionals with strong leadership skills - there are a number of direct reports into this global role International regulatory markets experience is essential Entrepreneurial, commercial and growth mindset required There will be some travel required Hybrid working environment, 3 days required on-site in Dublin Overseas candidates with all of the above (and below) experience and a permit to work in Ireland will be considered.
A relocation package will be offered.
About the Company: Join a dynamic, global, and fast-growing pharmaceutical organisation dedicated to improving the health of others by providing innovative and high-quality medicines that serve overlooked patients.
The company fosters a culture of collaboration, empowerment, and professional growth within a positive work environment.
It prides itself on a patient-centric approach and has a robust product portfolio across various therapeutic areas.
Employees are encouraged to develop and lead global strategies that maximize regulatory success and contribute to meaningful projects impacting millions of lives globally.
This is an exciting opportunity for a highly experienced and strategic leader to take on the role of Global Head of Regulatory Affairs.
The role focuses on navigating complex global regulatory landscapes and facilitating successful market entry for products.
Responsibilities: Oversee regional regulatory leads and staff to ensure global/regional regulatory strategies are written, reviewed, and executed according to plan.
Develop and implement global regulatory strategies for product development, registration, and lifecycle management, with a strong focus on new market entries.
Provide strategic and tactical advice to facilitate the timely and efficient conduct of all regulatory projects.
Establish and maintain a robust global regulatory framework, including policies, procedures, and best practices.
Ensure compliance with all applicable global regulations, guidelines, and standards (e.g., ICH, WHO).
Lead cross-functional initiatives and demonstrate leadership behaviors.
Direct and oversee multiple projects, ensuring regulatory compliance by staff and/or vendors.
Collaborate with other functions and vendors to ensure regulatory submissions and approvals are achieved on schedule.
Partner with access functions to support access applications, including pricing, reimbursement, and HTA.
Develop and lead direct reports, ensuring effective execution of regional regulatory strategies and fostering a culture of excellence and collaboration within the global regulatory affairs team.
Communicate developments that may impact regulatory success to project team colleagues and key stakeholders.
Anticipate risks and develop solutions to identified risks.
Accountable for all global submissions and approvals of projects.
Lead and manage interactions with regulatory authorities and agency meetings, including preparing for major health authority interactions and managing global regulatory interactions, negotiations, and inspections.
Conduct in-depth regulatory intelligence gathering and analysis to identify emerging trends and challenges in key markets.
Provide strategic guidance on regulatory pathways and requirements for diverse international regions (e.g., FDA, EU, Canada, ROW, APAC, LATAM).
Oversee the preparation and submission of global regulatory dossiers (e.g., NDAs, MAAs) to international regulatory agencies.
Lead the development and implementation of global labeling and packaging strategies.
Collaborate with clinical and commercial teams to integrate global regulatory requirements into product development and commercialization plans.
Requirements: MD, PhD, or PharmD in a scientific discipline preferred; Bachelor's degree in a scientific discipline (e.g., chemistry, biology, pharmacy) is required.
15+ years of experience in Regulatory Affairs with proven success in regulatory submissions and approvals, particularly in new markets.
Extensive knowledge of global regulatory requirements and guidelines, including experience with FDA, EU, Canada, ROW, and diverse international regulatory agencies.
Experience with investigational drugs, including late-stage development and marketed products.
Preferred experience in CRO management and prior managerial experience supervising regulatory professionals.
Strong leadership skills with the ability to inspire and motivate teams.
Excellent oral and written communication skills, capable of presenting data to both technical and non-technical audiences.
Excellent interpersonal and communication skills, with the ability to influence and negotiate effectively.
Proficient in MS Office, particularly Excel, PowerPoint, and MS Project.
Fluent in English (written and oral).
Experience working in a geographically dispersed and culturally diverse workforce.
Experience in emerging markets regulatory.
Strong understanding of market access strategies.
Please contact Sarah Kelly, Partner, The Panel, to discuss in confidence.
Seniority level Director
Employment type Full-time
Job function Legal and Science
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr
