Associate Director/Director, Regulatory Affairs CMC

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Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, Alkermes applies our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. Our track record for successful drug development is evident from the more than 20 marketed drugs that use our proprietary technologies, and perhaps most clearly exemplified by the five key commercial products propelling our growth. These are products in major disease areas, such as schizophrenia, addiction, and multiple sclerosis.Alkermes is in an exciting phase of growth that few biotechnology companies achieve, with our diversified portfolio of commercial products and an exciting late-stage pipeline. We are moving ahead with global capabilities, an established approach to innovation, world-class manufacturing, financial strength, and our experienced and dedicated people.Position Overview:This position will be responsible for providing strategic Regulatory CMC management and direction to Alkermes’ Pharma business projects/products. This position will be located in our Waltham, MA facility.Major Duties/ResponsibilitiesResponsible for planning and execution of Regulatory CMC activities related to early phase and late phase development marketed products. Responsible for regulatory submissions and compliance activities for IND, CTA, NDA, and DMF’s. Responsible for ensuring timely completion and support of submission of periodic Regulatory reports to include IND/NDA/DMF annual reports.Responsible for representing Regulatory Affairs within various committees, project teams, improvement teams and product development teams as team leader or team member.Responsible for providing regulatory and scientific expertise as guidance writing and reviewing for all CMC sections of regulatory applications and/or submissions to ensure successful filings & compliance with FDA requirements.Responsible for maintaining dialogue with regulatory agencies/personnel in support of Alkermes applications. Provide Regulatory support on defined/project basis as requested by the Sr. Director Regulatory Affairs.Develop personal and project objectives that provide support for overall business goals.Minimum Education and Experience Requirements:Bachelor of Science (or equivalent degree) in a scientific discipline.Minimum of 8-10 years regulatory pharmaceutical experience for Associate Director level.10+ years regulatory pharmaceutical experience for Director level.Special TrainingCapability in Electronic Submission Template is preferredExperience/background and training in all aspects of Regulatory Affairs including:working knowledge of the drug development process FDA requirements for INDs, ANDAs, NDAs, DMF’s ability to analyze and resolve problems or perform tasks in accordance with SOPs, the CFR and Guidelines, cGMPs, cGLPs, and cGCPsPeople Management / Supervisory experienceTravel:10% travel is required of this role. Travel will be primarily domestic, with some occasional international. This amount will be expected to increase during times of peak project demand.For more information about Alkermes or to apply to a position, please visit our website at www.alkermes.com and search our Careers page.Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.