Regulatory Operations 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 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...

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...

Job Title: Regulatory Operations Specialist Key Responsibilities:Develop and execute regulatory strategies to manage operational activities across assigned regions.Contribute to the development of the global regulatory strategy, providing input into the Regulatory Functional Plan (RFP) and Seed Document.Collaborate with regional teams to ensure alignment on...

Regulatory Affairs Specialist">We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory group, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the approval of our products.">Lead submission for annual reports, facility registrations, facility renewals,...

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 SummaryAs a Regulatory Affairs Manager, you will play a key role in supporting the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.Key Responsibilities:Develop and implement standardized templates and structured data formats to ensure consistent and compliant submissions.Contribute to...

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...

Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role is responsible for ensuring compliance with regulations and policies, as well as providing support for research and development activities.About the Role:This is a dynamic opportunity for a motivated individual who is passionate about...

Key Responsibilities:Develop and execute regulatory strategies to ensure timely submissions and approvals for assigned regions.Collaborate with regional teams to align on regulatory approaches and contribute to the development of departmental goals and objectives.Provide input into global regulatory strategy and participate in relevant regulatory boards to...