Regulatory Affairs Director

hace 4 semanas


Barcelona, Barcelona, España Sandoz A tiempo completo

As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API department, driving and delivering high-quality documentation to support successful submissions. Your responsibilities will include leading, coaching, and mentoring associates, ensuring sufficient training and development opportunities to maximize regulatory competence. You will also be responsible for financial targets, including cost center responsibility, and ensure timely and accurate reporting of regulatory activities. Additionally, you will analyze group performance, make recommendations for improvement, and coordinate the preparation and execution of regulatory documents. You will formulate and lead global regulatory strategy, focusing on maximizing business benefit while ensuring regulatory compliance. You will also generate, review, and approve internal regulatory guidance documents, protocols, and reports within assigned projects. Your expertise in regulatory guidelines and requirements in global regions and new technical trends will be essential in this role. You will be responsible for transferring knowledge and experiences to the organization and liaising with regulatory agencies, representing the company in regulatory meetings and discussions. You will work according to internal and external guidance, SOPs, and respective timelines. To be successful in this role, you will need a PhD in a natural science field, such as chemistry, pharmacy, or biology, with at least 3 years of work-related post-doctoral or industrial experience, or a Master's or Bachelor's degree in a related field with similar experience. Leadership experience within the regulatory affairs function is also required. You will need broad knowledge of regulatory guidelines, good knowledge of relevant software tools, and good skills in presentation and scientific/technical writing. Fluency in English and Spanish is also essential. If you have a strong background in regulatory affairs and are looking for a challenging role, this could be the opportunity for you. At Sandoz, we are committed to developing and delivering high-quality generic and biosimilar medicines that meet the needs of patients and healthcare professionals.



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