Job Description
• Obtaining and maintaining product licenses for marketing affiliate by filing submissions to local regulatory agency;
• being knowledgeable on all aspects of regulatory affairs and aware of the latest applicable national legislation and guidance as well as the latest regional legislation and/or ICH guidance if applicable;
• developing, updating and implementing appropriate SOPs as required by Global Regulatory Affairs policies;
• be responsible for the interaction with the national regulatory agency for providing regulatory responses and resolving issues directly with local regulators and product quality related matters;
• ensure local GMP contractors and local GMP service providers that distribute transport or store products meet quality expectations, through periodic audit conducted by him/ herself. Provide Quality Agreements describing responsibilities in place;
• participate, prepare, evaluate and approve written responses to Global Quality Assurance audits and GMP regulatory agency inspections, and provide monthly progress reports on the status of actions committed to in the response to those observations;
• be reported by every individual at the affiliate of information that could potentially result in a recall, correction or market withdrawal, and escalate it as appropriate, playing the role of Recall Coordinator if Affiliate Management designates him/her as that;
• ensure the appropriate labeling review and approval processes are in place;
• approve training courses and materials regarding product quality operations and assist to ensure all personnel are trained;
• ensure a system is in place at each affiliate to manage physician-sampling programs according to product quality requirements;
• determine the impact of product quality-related failures and/or incidents in the affiliate, investigate, notify and evaluate with the RQL;
• evaluate and approve, prior to implementation, all proposed changes that affect affiliate and be responsible that implementation is completed according to the change proposal.
• being knowledgeable on all aspects of regulatory affairs and aware of the latest applicable national legislation and guidance as well as the latest regional legislation and/or ICH guidance if applicable;
• developing, updating and implementing appropriate SOPs as required by Global Regulatory Affairs policies;
• be responsible for the interaction with the national regulatory agency for providing regulatory responses and resolving issues directly with local regulators and product quality related matters;
• ensure local GMP contractors and local GMP service providers that distribute transport or store products meet quality expectations, through periodic audit conducted by him/ herself. Provide Quality Agreements describing responsibilities in place;
• participate, prepare, evaluate and approve written responses to Global Quality Assurance audits and GMP regulatory agency inspections, and provide monthly progress reports on the status of actions committed to in the response to those observations;
• be reported by every individual at the affiliate of information that could potentially result in a recall, correction or market withdrawal, and escalate it as appropriate, playing the role of Recall Coordinator if Affiliate Management designates him/her as that;
• ensure the appropriate labeling review and approval processes are in place;
• approve training courses and materials regarding product quality operations and assist to ensure all personnel are trained;
• ensure a system is in place at each affiliate to manage physician-sampling programs according to product quality requirements;
• determine the impact of product quality-related failures and/or incidents in the affiliate, investigate, notify and evaluate with the RQL;
• evaluate and approve, prior to implementation, all proposed changes that affect affiliate and be responsible that implementation is completed according to the change proposal.
Requirements
• Relevant scientific degree or Bachelor's degree in physical or biological sciences required;
• requires business and technical knowledge within discipline and understanding of key business drivers;
• comprehensive knowledge and understanding of local and global regulatory procedures as well as European ones as applicable;
• ability to manage multiple tasks simultaneously, attention to detail and organizational skills;
• good organizational and communication skills;
• ability to work independently and to respond effectively and quick to urgent situations;
• fluency in English is an absolute requirement as well as an ability to communicate effectively with others and manage effectively your time;
• basic computer skills (Microsoft Word, Excel, Windows XP);
• previous experience in regulatory affairs or a related field (would be an advantage).
• requires business and technical knowledge within discipline and understanding of key business drivers;
• comprehensive knowledge and understanding of local and global regulatory procedures as well as European ones as applicable;
• ability to manage multiple tasks simultaneously, attention to detail and organizational skills;
• good organizational and communication skills;
• ability to work independently and to respond effectively and quick to urgent situations;
• fluency in English is an absolute requirement as well as an ability to communicate effectively with others and manage effectively your time;
• basic computer skills (Microsoft Word, Excel, Windows XP);
• previous experience in regulatory affairs or a related field (would be an advantage).
Company offers
• Real possibility to implement your professional ambitions;
• work in international environment where members are a value;
• dynamic workplace;
• motivating salary.
• work in international environment where members are a value;
• dynamic workplace;
• motivating salary.
