.**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeThe North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client deliverables meet current local, regional, and ICH regulatory and technical requirements. The RAL acts as a liaison with internal and external clients and oversees the preparation and submission of regulatory documentation.**Essential Functions**:- Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.- Ensures quality performance for key/managed projects.Manages project budgeting/forecasting functions.- Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.- Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.- Provides matrix/project leadership, training and guidance to junior team members.- Ensures compliance with relevant organizational and regulatory SOPs and WPDs.- Participates in launch meetings, review meetings and project team meetings**New Tasks and Responsibilities**:- Accountable and responsible for overseeing all submission types to Regulatory Authorities and/or EC/other local submissions, including North America IRB submissions.- Ensure adherence to standard RAL procedures applicable to EC and RA submissions.- Oversee the development, translation, and filing of country and site-specific submission-related documents for RA, US IRBs and Canadian ECs submissions- Ensure that submission-related documents are received within the agreed timeline and filed according to agreed processes.- Inform all Lead RAL and/or functional leads of the required deadlines for submission document availability.- Liaise with Lead RAL and/or responsible functional leads in the CRG internal team to ensure documents required for submission are ready in time as per the submission plan.**Working Conditions and Environment**:- Work is performed in an office environment with exposure to electrical office equipment.- Occasional drives to site locations with occasional travel, both domestic and international.**Physical Requirements**:- Coordinate all North America IRB activities and ensure that essential document quality meets the expectations of Regulatory Compliance Review.- Ensure timely North America regulatory and/or IRB submissions and follow up on all questions raised by ethics committees.**Management Role**:- No management responsibility