Regulatory Affairs Officer CMC – Biological products Specialist

Asphalion is growing, and we are looking for a Regulatory Affairs Officer to join our CMC unit of consultants for the pharmaceutical industry We seek someone who loves new challenges, enjoys working in an international environment, and wants to grow with us. Main responsibilities : Reporting to: CMC Manager Managing global CMC documentation, including...

Regulatory Affairs Specialist - CMC UnitWe are seeking a highly motivated Regulatory Affairs Specialist to join our CMC unit. The ideal candidate will have strong experience in CMC regulatory affairs and excellent communication skills.Main Responsibilities:CRC Officer: Reporting to the CMC Manager, responsible for overall CMC writing/management of...

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team.This role will involve working on the preparation and submission of regulatory documents, including CMC dossiers, new registration applications, and variation packages. You will also be responsible for providing support in responses to deficiency letters,...

As a highly skilled Regulatory Affairs Officer, you will play a critical role in the success of our company's pharmaceutical projects. Your primary responsibility will be to manage and write product-specific dossiers, new registration applications, variation packages, and renewal packages for various markets.Main Responsibilities:Congressional Liaison:...

We need a detail-oriented and organized individual to fill the position of Regulatory Compliance Officer.In this role, you will be responsible for ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, including CMC dossiers, new registration applications, and variation packages. You will also provide support in...

About the RoleThis is an exciting opportunity to join our organization as a Regulatory Affairs Manager, where you will play a vital role in ensuring compliance with regulatory and legal requirements.The successful candidate will be responsible for developing and executing a regulatory strategy to support the registration of products, preparing and analyzing...

Regulatory Affairs Manager Job Description">Overview:">We are seeking an experienced Regulatory Affairs professional to play a vital role in our team. This position focuses on cross-functional activities, managing documentation and ensuring compliance with regulatory and legal requirements.">Responsibilities:">Developing and executing a regulatory strategy...

Regulatory Affairs SpecialistWe are looking for a highly motivated Regulatory Affairs Specialist to contribute to our team's success. As a key member, you will be responsible for various tasks related to CMC, including writing and managing product-specific dossiers.Key Responsibilities:Manage CMC dossiers, ensuring compliance with regulatory...

Take your career to the next level by overseeing and managing the change control system within a client's company. This role is critical in ensuring compliance with CMC regulatory requirements, maintaining product quality, and facilitating efficient project execution.About the JobWe are seeking a highly skilled and experienced Project Manager to lead our...

We are seeking a skilled Regulatory Affairs Senior Officer to join our team of development, strategy, and scientific writing experts. As a Medical Writer, you will be responsible for the timely and accurate execution of projects according to defined timelines.Main Responsibilities• Writing regulatory documents to support drug development (SA, PIP, ODD,...