REGULATORY AFFAIRS MANAGER

Regulatory Affairs Manager - 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. **Education and Experience**:Bachelor''s degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9+ years). **Knowledge, Skills and Abilities**:- Good English language (written and oral) communication skills as well as local language where applicable- Good attention to detail and quality as well as editorial/proofreading skills- Good interpersonal skills to work effectively in a team environment- Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning newtechnologies- Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects- Good negotiation skills- Capable of working independently with direction and exercising independent judgment- Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables- Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management- Basic understanding of medical terminology, statistical concepts, and guidelines- Good analytical, investigative and problem-solving skills- Capable of interpreting data