Regulatory Affairs Associate Director
hace 1 semana
As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project plans. This includes preparation of registration documentation and assessment of appropriateness of registration documentation for active ingredients/intermediates.Your responsibilities will include:Lead, coach and mentor associates. Ensure sufficient training and development opportunities to maximize regulatory competence.Take responsibility for financial targets including but not limited to cost center responsibility.Ensure and/or support timely and accurate reporting of regulatory activities.Perform and/or support analyzing group performance and making recommendations for improvement within the team.Coordinate the preparation and execution of regulatory documents. Ensure regulatory CMC submissions are of high quality, consistent and complete, and comply with current global regulatory standards.Formulate, lead and drive global regulatory strategy with a focus on maximizing business benefits balanced with regulatory compliance for drug substances.Generate, review and approve internal regulatory guidance documents, protocols, and reports within assigned projects.Establish and maintain sound working relationships with colleagues, partners, and customers. Provide regulatory guidance to cross-functional teams, and determine regulatory impact for changes in chemistry, manufacturing, and control procedures. Support and/or lead global regulatory projects/initiatives.Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions as well as for new technical trends. Responsible for the transfer of knowledge and experiences to the organization.Liaise under minor supervision with regulatory agencies and represent the company in regulatory meetings and discussions.Work according to internal and external guidance, SOPs, and respective timelines.What you'll bring to the role:PhD (natural science: chemistry, pharmacy, biology or related fields) with at least 3 years of work-related post-doctoral/industrial experience, or Master/BSc (natural science: chemistry, pharmacy, biology or related fields) with at least 3 years of work-related experience including people management experience.Leadership experience within the regulatory affairs function.Broad knowledge of Module 3.Broad knowledge of regulatory guidelines.Good knowledge of relevant software tools.Good skills in presentation and scientific/technical writing.Good documentation skills and ability to understand and follow written procedures accurately.Fluent oral and written English. Fluent in Spanish.Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do moreWith investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouragedThe future is ours to shapeCommitment to Diversity & Inclusion:Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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España Sandoz A tiempo completoAs Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation for...
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