Principal Regulatory Affairs Consultant
7 days ago
When our values align, there's no limit to what we can achieve.
Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval CMC activities. As a recognized professional in your field of expertise, you will utilize your rainmaking skills and extensive knowledge of our consulting models and methodologies to deliver exceptional consulting services to our clients. This is a unique opportunity to showcase your technical skills, specialist knowledge, and mentorship abilities.
This role can be home or office based in various European locations.
Key Responsibilities:
Serve as a Project Leader, providing overall project leadership and ensuring the project's successful planning and set-up.
Act as the main client contact, maintaining accurate project reporting and delivering to meet client expectations.
Develop and implement submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
Assess change controls and provide regulatory assessments of quality changes in production and quality control.
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
Coordinate submission preparation with various departments, including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
Write and review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
Collaborate within a team environment to deliver project requirements. Prioritize workloads, both for yourself and the project team, to achieve project scope and objectives.
Deliver engaging presentations at seminars and industry group meetings. Author articles for industry publications, demonstrating expertise and showcasing Parexel's capabilities.
Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
Mentor and coach more junior members of the team.
Collaborate with Account Management to prospect and leverage new business opportunities.
Effectively communicate Parexel's service offerings, demonstrating our capability to support client needs.
Experience and Skills Required:
University-level education in Life Sciences or equivalent by experience.
Extensive experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
Strong understanding of CMC and post-approval regulatory requirements.
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
Knowledge of small molecule processes.
Proficient account planning and support abilities.
Networking skills to expand professional connections.
Team spirit, flexibility, accountability, and organizational skills.
Strong project leadership and management knowledge.
Strong business acumen for analysis and decision-making.
Self-confidence and control in professional engagements.
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
Fluent in English (written and spoken).
-
Regulatory Affairs Specialist
7 days ago
Dublin, Dublin City, Ireland Collins McNicholas Recruitment Full timeOur Client, a globally recognized leader in healthcare innovation, based in Athlone, Co. Westmeath, is seeking a Senior Regulatory Affairs Specialist to join their team. The successful person will take charge of managing regulatory activities and projects, developing regulatory strategies for new products, and handling submissions to regulatory authorities...
-
Head of Regulatory Affairs
6 hours ago
Dublin, Dublin City, Ireland Blackhawk Network (GVS) Full time**Head of Regulatory Affairs:We are seeking a highly experienced professional to join our team as a Head of Regulatory Affairs. In this role, you will be responsible for leading our regulatory affairs function and ensuring that our business operations are in compliance with all relevant regulations and laws.The ideal candidate will have extensive knowledge...
-
Regulatory Affairs
1 week ago
Dublin, Dublin City, Ireland Thornshaw Recruitment Full timeThornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have a new opportunity for a Regulatory Affairs Officer to join the Dublin team.Key Responsibilities:Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for our current portfolio of pharmaceutical...
-
Regulatory Affairs Manager
2 weeks ago
Dublin, Dublin City, Ireland Parexel Full timeWhen our values align, there's no limit to what we can achieve. Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team This is a client dedicated project, and the role can be office or home based in various...
-
Regulatory Affairs Expert
17 hours ago
Dublin, Dublin City, Ireland TN Ireland Full timeOpportunity OverviewWe are seeking a Regulatory Affairs Expert to join our team in the UK, Germany, Ireland, or Switzerland. As a key member of our Biocides Regulatory Team, you will provide regulatory and technical expertise to support the approval of new and existing active substances at community level and the authorisation of biocide products on a...
-
Regulatory Affairs Manager
7 days ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeRegulatory Affairs ManagerMy client, a multinational medical device and health care company, is looking to recruit a Regulatory Affairs Manager. The Regulatory Affairs Manager will be in charge of managing teams within the Regulatory Affairs Sub-Function. The core focus of this position is on policy and strategy implementation and control rather than...
-
Regulatory Affairs Specialist
22 hours ago
Dublin, Dublin City, Ireland Mediolanum International Funds Limited Full timeJob Description:We are looking for a highly skilled Regulatory Affairs Specialist to join our Compliance Team at Mediolanum International Funds Limited. In this role, you will play a key part in ensuring the company's compliance with regulatory requirements and industry best practices.As a Regulatory Affairs Specialist, you will work closely with the...
-
Regulatory Affairs Officer
3 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeThornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now has a new opportunity for a Regulatory Affairs Officer to join the Dublin team. The same company also has Senior Regulatory Affairs Officer opportunities.Key Responsibilities:1. Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities,...
-
Director, Regulatory Affairs EU
2 weeks ago
Dublin, Dublin City, Ireland Emergent Biosolutions Full timeThose who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY The Director,...
-
Regulatory Affairs Director
9 hours ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeCpl Healthcare is a multinational medical device and health care company seeking a Regulatory Affairs Manager to lead its Regulatory Affairs Sub-Function. The successful candidate will be responsible for managing teams and overseeing the strategy implementation and operations for directing development of product registration submission, progress reports,...
-
Regulatory Affairs Director
22 hours ago
Dublin, Dublin City, Ireland Emergent Biosolutions Full time**About the Role**We are seeking a highly experienced Regulatory Affairs Director to lead our EU regulatory strategy and ensure compliance with global regulations.The successful candidate will have a strong understanding of the EU regulatory environment and be able to develop and implement effective strategies to obtain and maintain product licenses.Key...
-
Senior Regulatory Affairs Specialist
7 days ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeSenior Regulatory Affairs SpecialistOur client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the...
-
Regulatory Affairs Manager
1 day ago
Dublin, Dublin City, Ireland Flexjet Europe Full timeWe are seeking an experienced Regulatory Affairs Manager to join our team at Flexjet Europe. In this role, you will be responsible for ensuring that the organization remains compliant with aviation regulations and standards.This will involve performing internal audits, analyzing compliance data, and creating reports to support timely and effective closure of...
-
Director, Regulatory Affairs EU
3 weeks ago
Dublin, Dublin City, Ireland Emergent BioSolutions Full timeSelect how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...
-
Director, Regulatory Affairs EU
1 week ago
Dublin, Dublin City, Ireland Emergent BioSolutions Full timeSelect how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...
-
Director, Regulatory Affairs EU
5 days ago
Dublin, Dublin City, Ireland Emergent BioSolutions Full timeSelect how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...
-
Director, Regulatory Affairs EU
1 week ago
Dublin, Dublin City, Ireland Emergent BioSolutions Full timeSelect how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...
-
Dublin, Dublin City, Ireland Vectura Group plc Full timeSenior Manager Regulatory Affairs for Medical Devices and Person ResponsibleVectura Ireland Limited is seeking a Senior Manager in Regulatory Affairs for Medical Devices who will also assume the critical role of Person Responsible for Regulatory Compliance (PRRC). This position plays a key role in ensuring compliance with European medical device regulations...
-
Regulatory Affairs Senior Specialist
3 weeks ago
Dublin, Dublin City, Ireland Xeolas Full timeDublin, Ireland - Permanent Full Time RoleXeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufacture innovative patient-friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Affairs Senior Specialist as we expand.Overall Role...
-
Regulatory Affairs Senior Specialist
7 days ago
Dublin, Dublin City, Ireland Xeolas Full timeDublin, Ireland - Permanent Full Time RoleXeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufacture innovative patient-friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Affairs Senior Specialist as we expand.Overall Role...