Alexion Pharmaceuticals
Director, Regulatory Affairs, Regulatory Science & Execution
Alexion Pharmaceuticals, Boston, Massachusetts, United States, 02108
Regulatory Affairs Director (RAD)
The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation, and maintenance of regulatory strategies for assigned projects/products and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide tactical and strategic input to and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities. You will be responsible for: Accountable as Regulatory Lead to develop and implement regulatory strategies for assigned highly complex project(s)/product(s) across the assigned jurisdiction(s) and accountable to provide regulatory advice to cross-functional strategies and associated deliverables according to business objectives with limited oversight. Accountable for the regulatory execution of submissions in the relevant regulatory jurisdiction(s), by actively collaborating with other Regulatory functions and cross-functional teams (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, paediatric submissions, etc.). Leading the planning and conduct of regulatory authority meetings in relevant jurisdiction(s), in alignment with global regulatory and cross-functional strategy. Representing Alexion as point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders. Actively collaborating with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight and broader drug development expertise. Actively staying up to date on latest regulatory requirements and trends, and contributing to the shaping of the regulatory science environment. Supporting regulatory intelligence and policy priorities based on Alexion and AstraZeneca's internal knowledge and expertise. Championing opportunities for regulatory innovation approaches and presenting such strategies and plans to management and appropriate cross-functional teams. Supporting relevant internal activities, including development and management of select Regulatory processes and procedures, as well as inspection/audit support. Demonstrating strategic leadership skills contributing to effective product development. Providing team leadership and participating in mentoring, and performance feedback to regulatory and cross-functional colleagues. Ensuring exemplary behavior, leadership, ethics, and transparency within the Enterprise, with Health Authorities and other external stakeholders. You will need to have: 8+ years of relevant Regulatory experience in the pharmaceutical industry, with experience in US regional regulatory strategies. Bachelor's Degree Strong knowledge of drug development and regulatory environment, coupled by excellent scientific and business judgment. Experience providing strategic regulatory advice in several regulatory jurisdiction(s) (e.g. EU, US, Canada, UK) for the global development of products through all stages of development including pre-approval and marketed assets. Ability to manage complex issues and lead multiple projects simultaneously in a time-sensitive fashion. Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management. Strong interpersonal, written/verbal communication and presentation skills. Proven track record practicing sound judgment as it relates to risk assessment. Highly familiar and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information. Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation, and maintenance of regulatory strategies for assigned projects/products and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide tactical and strategic input to and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities. You will be responsible for: Accountable as Regulatory Lead to develop and implement regulatory strategies for assigned highly complex project(s)/product(s) across the assigned jurisdiction(s) and accountable to provide regulatory advice to cross-functional strategies and associated deliverables according to business objectives with limited oversight. Accountable for the regulatory execution of submissions in the relevant regulatory jurisdiction(s), by actively collaborating with other Regulatory functions and cross-functional teams (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, paediatric submissions, etc.). Leading the planning and conduct of regulatory authority meetings in relevant jurisdiction(s), in alignment with global regulatory and cross-functional strategy. Representing Alexion as point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders. Actively collaborating with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight and broader drug development expertise. Actively staying up to date on latest regulatory requirements and trends, and contributing to the shaping of the regulatory science environment. Supporting regulatory intelligence and policy priorities based on Alexion and AstraZeneca's internal knowledge and expertise. Championing opportunities for regulatory innovation approaches and presenting such strategies and plans to management and appropriate cross-functional teams. Supporting relevant internal activities, including development and management of select Regulatory processes and procedures, as well as inspection/audit support. Demonstrating strategic leadership skills contributing to effective product development. Providing team leadership and participating in mentoring, and performance feedback to regulatory and cross-functional colleagues. Ensuring exemplary behavior, leadership, ethics, and transparency within the Enterprise, with Health Authorities and other external stakeholders. You will need to have: 8+ years of relevant Regulatory experience in the pharmaceutical industry, with experience in US regional regulatory strategies. Bachelor's Degree Strong knowledge of drug development and regulatory environment, coupled by excellent scientific and business judgment. Experience providing strategic regulatory advice in several regulatory jurisdiction(s) (e.g. EU, US, Canada, UK) for the global development of products through all stages of development including pre-approval and marketed assets. Ability to manage complex issues and lead multiple projects simultaneously in a time-sensitive fashion. Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management. Strong interpersonal, written/verbal communication and presentation skills. Proven track record practicing sound judgment as it relates to risk assessment. Highly familiar and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information. Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.