Post-Approval Regulatory Expert

Parexel, a leading Clinical Research Organization (CRO), is seeking an experienced Principal Regulatory Affairs Consultant to join their team in Warsaw. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.This is a...

TN Poland is seeking a highly qualified Principal Regulatory Affairs Consultant to join their team in Warsaw. The successful candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.This is a unique opportunity for a highly qualified...

About the Role:GSK's Global Regulatory Centres are responsible for regulatory affairs functions, bringing together operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, license maintenance, and lifecycle management dossiers.We are seeking a highly skilled Regulatory...

as Manager, Regulatory Affairs Established Products, you will be responsible for the regulatory support of a portfolio of established oncology and internal medicine products. Your objective will be to ensure compliance with regulatory requirements and to implement the global regulatory strategy for post-approval products.Regulatory Affairs Established...

ResponsibilitiesMaintain the integrated Regulatory Development Plan (RDP) to operationalize the Global Regulatory Strategy, ensuring accurate capture of regulatory deliverables, timelines, and resource needs for each phase of development.Provide Regulatory functional line planning support for multiple projects from Commit to Candidate (C2C) through...

About the JobWe are seeking an experienced regulatory professional to join our dynamic team as a CMC Regulatory Manager. This client-dedicated project offers flexibility, with the option to work from home or office in various European locations.As the CMC Regulatory Manager, you will play a key role in our company's worldwide post-approval regulatory...

TN Poland is seeking a highly qualified Principal Regulatory Affairs Consultant to lead their regulatory affairs efforts in Warsaw.The successful candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.This role offers a unique...

Job ResponsibilitiesDevelop submission strategies and plans for post-approval CMC activities such as 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...

Job Description:GSK is a global biopharma company that unites science, technology, and talent to get ahead of disease together. Our ambition is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.We are looking for a skilled Regulatory Affairs Specialist to join our team in Poland. As a key member...

We are seeking a skilled Senior Regulatory Expert to join our team at TN Poland. As a key member of our Scientific and Regulatory Affairs department, you will be responsible for ensuring that our products comply with all relevant laws and regulations in assigned markets.Your primary focus will be on assuring ingredients, formulas, labeling, and packaging...

Are you looking for a challenging role that combines technical expertise with business acumen? TN Poland is seeking a highly qualified Principal Regulatory Affairs Consultant to lead their regulatory affairs efforts in Warsaw.The successful candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of...

We are seeking an experienced Regulatory Expert to join our team in Warsaw. As a key member of our Global Business Center, you will be responsible for regulatory client communication within the C&IB division.This is an exciting opportunity to be at the forefront of regulatory change and drive end-to-end client communication related to EMIR Refit as well as...

About the RoleWe are seeking a highly skilled Regulatory Submission Expert to join our team in Warsaw, Poland.As a Regulatory Submission Expert, you will be responsible for ensuring that all regulatory submissions are accurate, complete, and submitted in a timely manner.Preparing regulatory submissions (e.g., Development Safety Update Reports, Periodic...

About the RoleWe are seeking a highly skilled CMC Regulatory Expert to join our team at GSK. As a key member of our cross-functional matrix project teams, you will be responsible for managing CMC regulatory activities required during the lifecycle of GSK products.Responsibilities:Managing multiple CMC variations and source transfers of GSK's APIs,...

Role OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Innovaderm. As a key member of our regulatory department, you will be responsible for ensuring compliance with applicable EU regional regulations and guidelines.The ideal candidate will have a strong background in clinical research, excellent knowledge of GCP and...

For our Client, one of the biggest Pharmaceutical Companies worldwide we are looking for a Senior RA Professional EMEA, who will be responsible for supporting the Regulatory Liaison (RL) for a broad range of regulatory activities in the Established Products area in the Europe/Middle East/Africa (EMEA) region, providing regulatory input on submission...

Role OverviewWe are seeking a highly skilled Regulatory Affairs Expert to join our team at Randstad Polska Sp. z o.o.The successful candidate will be responsible for ensuring compliance with regulations and interpretations of regulatory agencies in the pharmaceutical industry.This is an exciting opportunity for a motivated individual to contribute to the...

Role OverviewThe Regulatory Specialist will be responsible for the development and management of Pharmacovigilance Risk Management Plans (PV-RMPs) to support drug and biologic products.This position is part of the Risk Management function within the organization, responsible for facilitating cross-functional review and approval of PV-RMPs.The ideal candidate...

Job DescriptionThe Risk Management Expert will be responsible for the development and management of PV-RMPs to support drug and biologic products.This position requires prior experience with worldwide PV-RMP regulations, particularly in the European Union (EU), and excellent analytical and critical thinking skills.The ideal candidate will facilitate...

Randstad is seeking a talented Compliance and Regulatory Expert to work on a critical project. The successful candidate will be responsible for managing the operational submission process and delivering regulatory submissions to support product development, registration, and compliance.About the Role:This is an exciting opportunity to work with a large...