Regulatory Change Specialist

Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for maintaining close cooperation with regulatory authorities to discuss requirements, strategies, and knowledge of global product dossiers to stay up-to-date.Maintain close cooperation with regulatory...

Job TitleWe are seeking a Regulatory Compliance Change Specialist to collaborate with global, site, and regulatory teams. This role is responsible for assessing single or cross-product changes, ensuring that all product-related changes adhere to regulatory requirements.Change Assessment: Evaluate change records to assess reportability and product...

Regulatory SpecialistWe are seeking a highly skilled Regulatory Specialist to join our team. This role will involve managing the regulatory life cycle of drug products, including pre and post approval processes.Key Responsibilities:Managing regulatory submissions, including preparation and delivery of regulatory maintenance submissions from a global and/or...

Regulatory Compliance SpecialistWe are seeking a skilled Regulatory Compliance Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs and a proven track record of ensuring compliance with global product dossiers.Key Responsibilities:Maintain close cooperation with RA CMC to discuss regulatory requirements,...

Job SummaryRegulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team.The successful candidate will be responsible for the preparation and review of regulatory documents, including dossiers, briefings books, and labeling.They will also coordinate with internal stakeholders and external counterparts to review...

Regulatory Affairs Specialist JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic inputs to support the development and launch of new products.The successful candidate will have a strong...

Job Description:We are seeking a highly motivated and detail-oriented professional to join our team as a Regulatory Affairs Specialist. The successful candidate will be responsible for preparing and submitting drug product submissions to Health Canada, ensuring accuracy and compliance with regulatory requirements.Key Responsibilities:Prepare and submit...

Job Title: Regulatory Operations SpecialistWe are seeking a highly skilled and experienced Regulatory Operations Specialist to join our team.

Job Title: Regulatory Writing Specialist\ Job Summary: We are seeking a skilled Regulatory Writing Specialist to join our team. This role involves creating high-quality documents for regulatory submissions, including clinical study reports, observational research study reports, and plain language summaries. The successful candidate will have excellent...

Job Summary:A highly skilled Regulatory Compliance Change Assessor is required to review change records, evaluate the impact of changes on reportability and product restrictions, and ensure regulatory strategies are aligned across functions.Key Responsibilities:Evaluate the impact of changes on reportability and product restrictions for products in...