همکار امور رگولاتوری

Job Description

The objective of the role: Regulatory Affairs Partner (RAP) will lead and oversee the development, implementation, and ongoing management of regulatory strategies, regulatory activities, and regulatory submissions and associated activities to ensure the rapid and optimal registration of new products and indications. RAP will ensure ongoing regulatory compliance and maintain existing registrations throughout a product’s lifecycle and works closely with health authorities in Iran. RAP will also ensure the local operation is fully compliant at all times with Roche regulatory policies and procedures, governing legislation, and regulatory requirements. Responsibilities: Regulatory operations: ● Manage affiliate regulatory activities on relevant Roche systems in a timely manner. ● Ensure regulatory inspection-readiness for the affiliate, as per assigned responsibilities. ● Ensure regulatory compliance for product information and regulatory registration filings across the product lifecycle. ● Manage end-to-end product packaging and labeling within the Roche system. ● Provide regulatory expertise and input into local promotional materials. ● Represent affiliate regulations in cross-functional teams. ● Document alignment impact assessment and adopt global procedures to local requirements. ● Support quality and safety activities from a regulatory perspective. ● Archive paper and electronic regulatory records according to core map principles ecosystem stakeholders. Regulatory strategy: ● Identify key issues and develop strategies for successful regulatory activities for all Pharma products across the affiliate. ● Ensure internal partner/stakeholder input is solicited and incorporated into regulatory strategies. ● Determine regulatory project priorities and the timing for such. ● Keep cross-functional partners and stakeholders abreast of key regulatory activities, progress, and outcomes. Includes communicating any real or potential risks or other issues. ● Develop and maintain professional and credible relationships with internal partners/stakeholders, health authorities, and customers. Communication/other: ● Lead or participate in special projects or other initiatives. ● Oversee interactions and communications with multidisciplinary teams involved in regulatory strategies, projects, and submissions. Includes planning and ongoing liaison with local, regional, and global partners/stakeholders. ● Communicate with or otherwise oversee communications with health authorities and key customers.