Global Regulatory Strategy Leader

Key AccountabilitiesAs a seasoned regulatory professional, your primary responsibilities will involve developing and implementing global regulatory strategies to ensure timely submissions and approvals. You will collaborate closely with regional teams to align on regulatory approaches and facilitate the submission of dossiers worldwide.Main...

Job Title:A Manager is required to lead global CMC regulatory strategy.The ideal candidate will formulate and implement a proactive approach to maximize business benefit balanced with regulatory compliance.Liaise with cross-functional teams to ensure technical congruency and regulatory compliance.Prepare and communicate CMC Risk Management Assessments,...

Job Summary:We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team. As a key member of our organization, you will be responsible for formulating and leading global regulatory strategies that drive innovation and maximize business benefits while ensuring regulatory compliance.The ideal candidate will have a deep...

Job Overview:We are seeking a seasoned Regulatory CMC Manager to lead our global regulatory strategy and ensure compliance with all relevant regulations.Key Responsibilities:Develop and implement global CMC regulatory strategies, balancing business benefits with regulatory compliance.Lead global CMC submission activities, including planning, authoring,...

Job OpportunityTo ensure effective documentation systems, we are looking for a professional to oversee record retention and information services. This includes managing electronic records in line with regulatory requirements.Main ResponsibilitiesManage medium to small global submission projects with regulatory bodiesProvide submissions and contribute to the...

Regulatory Compliance SpecialistA key role that demands expertise in regulatory affairs and the ability to manage global CMC submission activities with strategic oversight.Key Responsibilities:Develop, implement, and maintain global CMC regulatory strategies that align with business objectives while ensuring compliance with regulatory requirements.Oversee...

Job Overview:The position of Global Regulatory Writing Manager is a leadership role that oversees the development and submission of regulatory documents. This includes Clinical Study Reports, Investigator Brochures, and other critical documents.This key leader will guide a team of writers to ensure timely completion of high-quality documents. A strong...

Global Regulatory Writing DirectorThis is a leadership position that requires strong expertise in regulatory writing, scientific data analysis, and project management.Responsibilities:Oversee the review and approval of regulatory submission documents.Lead functional area teams and maintain key relationships with cross-functional team members.Provide guidance...

Job DescriptionMajor accountabilities:- Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.- Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic...

Job Overview The International Program Regulatory Manager is a key role that supports the timely execution of registration plans for assigned portfolios in international countries. This position works under the supervision of the International Program Regulatory Director and partners with international regulatory teams and global line functions to drive...