Associate Director Regulatory Policy

ppbYour Key Responsibilities /b br/ Your responsibilities include, but not limited to: /p ul liDeveloping evidence-based policy positions for regulatory requirements for ethical and efficient development and manufacturing of generic and biosimilar medicines. /li liAligning Sandoz policy objectives and advocacy plans within Sandoz and within the trade association to shape emerging legislative proposals and regulatory guidelines of Health Authorities. /li liAdvocating for Sandoz policy objectives according to plans, e.g. via trade associations, conference presentations, publications, direct interactions with regulators and other relevant external stakeholders. /li liEvaluating the impact of regulatory requirements. /li liDeveloping materials and providing trainings for Sandoz employees on emerging regulatory requirements. /li liProviding strategic regulatory advice to development functions to support our pipeline products, e.g. to support Health Authority meetings, regulatory submissions, and life-cycle issues. /li liRepresenting Sandoz at trade associations and external working groups. Provide Sandoz perspectives to those associations and working groups and vice versa. /li liEstablishing and maintaining network with external stakeholders (policy makers, Health Authorities, industry peers, etc.). /li liCoordinating reviews of consultation documents as issued by Health Authorities. /li /ul h3Essential Requirements /h3 ul liMinimum 8 years of experience in regulatory affairs, drug development or policy development. Health Authority experience is an asset. /li liDemonstrable history of success over multiple years in a regulatory or health policy role with a strong understanding of the regulatory and legislative environment. /li liCommand of the drug development process, pharmaceutical business, and its regulation. /li liOrganizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams. /li /ul pbYour Key Responsibilities /b br/ Your responsibilities include, but not limited to: /p ul liDeveloping evidence-based policy positions for regulatory requirements for ethical and efficient development and manufacturing of generic and biosimilar medicines. /li liAligning Sandoz policy objectives and advocacy plans within Sandoz and within the trade association to shape emerging legislative proposals and regulatory guidelines of Health Authorities. /li liAdvocating for Sandoz policy objectives according to plans, e.g. via trade associations, conference presentations, publications, direct interactions with regulators and other relevant external stakeholders. /li liEvaluating the impact of regulatory requirements. /li liDeveloping materials and providing trainings for Sandoz employees on emerging regulatory requirements. /li liProviding strategic regulatory advice to development functions to support our pipeline products, e.g. to support Health Authority meetings, regulatory submissions, and life-cycle issues. /li liRepresenting Sandoz at trade associations and external working groups. Provide Sandoz perspectives to those associations and working groups and vice versa. /li liEstablishing and maintaining network with external stakeholders (policy makers, Health Authorities, industry peers, etc.). /li liCoordinating reviews of consultation documents as issued by Health Authorities. /li /ul h3Essential Requirements /h3 ul liMinimum 8 years of experience in regulatory affairs, drug development or policy development. Health Authority experience is an asset. /li liDemonstrable history of success over multiple years in a regulatory or health policy role with a strong understanding of the regulatory and legislative environment. /li liCommand of the drug development process, pharmaceutical business, and its regulation. /li liOrganizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams. /li /ul h3What you’ll bring to the role: /h3 ul liMinimum 8 years of experience in regulatory affairs, drug development or policy development. Health Authority experience is an asset. /li liDemonstrable history of success over multiple years in a regulatory or health policy role with a strong understanding of the regulatory and legislative environment. /li liCommand of the drug development process, pharmaceutical business, and its regulation. /li liOrganizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams. /li /ul pbPlease Note /b br/ This is a temporary fixed term role of 1 year to provide coverage during a period of employee absence.br/We also provide flexible working, learning and development opportunities. /p pbWhy Sandoz? /b br/ Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.br/With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.br/Our momentum is 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 careers, where diversity of thought is welcomed and where personal growth is supported!br/Join us, help us make healthcare fairer and faster. /p h3Commitment To Diversity Inclusion /h3 pWe are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. /p pb#Sandoz /b /p /p #J-18808-Ljbffr