Regulatory Affairs Specialist

Regulatory Affairs SpecialistThis role involves handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). It requires ensuring Regulatory Affairs compliance according to local legislation and Standard Operating Procedures (SOPs).Main Responsibilities:Prepare and submit Regulatory...

Regulatory Affairs Specialist Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Warsaw, Poland.Key Responsibilities:Prepare and submit regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards.Coordinate regulatory timelines and deadlines for all assigned projects...

Job Overview:Our client, a leading pharmaceutical company, is seeking a Regulatory Affairs Senior/Specialist in Submission Publishing. The successful candidate will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional, and global regulatory agencies and operating companies in both eCTD and non-eCTD...

We are seeking a seasoned Global Regulatory Affairs Specialist to join our team at Randstad. In this role, you will be responsible for managing the operational delivery of regulatory documents for product registration and compliance. Your expertise will help us ensure that all regulatory requirements are met, and our products reach the market...

For our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for a Regulatory Affairs Senior / Specialist in Submission Publishing who will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional and global regulatory agencies and operating companies in both eCTD and non-eCTD...

ManpowerGroup Sp. z o.o., a global leader in the employment services industry, is seeking a highly skilled Regulatory Affairs Specialist to join our team. With over 70 years of experience and operations in 82 countries, we are committed to providing our clients with top-notch recruitment solutions.Job SummaryWe are looking for an experienced Regulatory...

**About the Role:**We are seeking a highly skilled Regulatory Affairs Senior/Specialist to join our team at Randstad. As a key member of our team, you will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional, and global regulatory agencies and operating companies in both eCTD and non-eCTD format.The...

Job Title: Regulatory Affairs ProfessionalWe are seeking an experienced Senior Regulatory Affairs Professional to support the implementation of regional regulatory strategies for pharmaceutical products at various stages of their lifecycle.Closely collaborate with global and regional teams to effectively execute regulatory submission plans, support product...

Regulatory Affairs Manager/Senior Manager in Global LabelingWe are seeking a highly skilled Regulatory Affairs Manager/Senior Manager to join our team at {company}. This individual will be responsible for ensuring the quality of primary and derived labeling documents, providing support for these documents, and contributing to the global labeling strategy.Key...

**Job Title:** Manager, Regulatory AffairsContribute to Global Development and Lifecycle ManagementYou will lead the development and execution of global CMC regulatory strategies, ensuring compliance with regulatory requirements and representing Global CMC Regulatory Affairs in cross-functional and external collaborations.About This Opportunity:This is an...

At Randstad Polska Sp. z o.o., we are seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our global regulatory affairs function, you will play a pivotal role in shaping the development and lifecycle management of our groundbreaking pharmaceutical products.Your primary responsibilities will include leading the...

TN Poland is seeking a talented and experienced CMC Regulatory Affairs Professional to join our team. In this role, you will have the opportunity to utilize your expertise in CMC, exceptional communication skills, and strong writing experience, contributing to our clients' success in the pharmaceutical industry.This position offers exposure to novel...

About the RoleWe are seeking a highly skilled Regulatory Affairs Expert to join our team at RISK.The successful candidate will have experience in regulatory affairs, with strong knowledge of international commercial, contractual, and compliance law.You will be responsible for monitoring legal and regulatory developments in new and existing markets, as well...

IQVIA Argentina invites applications from experienced Regulatory Affairs Specialists to join our team. As a sponsor-dedicated professional in Poland, you will work closely with leading pharma companies to ensure compliance with regulatory requirements.About the Role:This is a challenging and rewarding role that involves conducting site selection, initiation,...

We are seeking a highly skilled Regulatory Affairs Manager to lead the development and maintenance of primary labeling for assigned compounds. This role requires strong leadership skills, as well as expertise in pharmaceutical regulatory guidelines.Key Responsibilities:Develop and maintain primary labeling documentsEnsure compliance with worldwide regulatory...

Job SummaryA highly skilled Regulatory CMC Manager is sought to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. This individual will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development.Key...

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...

GRC Regulatory Affairs ProfessionalThe Renewals CMC Team within the Global Regulatory Centres (GRC) is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. We are seeking a highly skilled Regulatory Specialist with expertise in Chemistry, Manufacturing, and Controls (CMC).Key...

We are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. In this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. This...

Step into a pivotal role as Manager, Regulatory Affairs and contribute to the global development and lifecycle management of groundbreaking pharmaceutical products. As a key member of team, you will lead the development and execution of global CMC regulatory strategies, ensure compliance with regulatory requirements, and represent Global CMC Regulatory...