Alkermes, incIs the u.sOperating company of alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areasAlkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncologyHeadquartered in dublin, ireland, alkermes has a research and development (“r&d”) center in waltham, massachusetts; an r&d and manufacturing facility in athlone, ireland; and a manufacturing facility in wilmington, ohio.
The following position is for alkermes, inc.
Alkermes is seeking a proven leader who is passionate about making a difference for patients suffering from serious diseases with a high unmet medical needThe vice president, global regulatory affairs will be responsible for overseeing the regulatory strategy function and will be responsible for the strategic development of our cns, neurology, and oncology products throughout the product lifecycleThis is a critical position that will play a key role in establishing and maintaining effective relationships with global health authorities, the global regulatory affairs organization, and cross-functional partners.
Success in this role requires a strong working knowledge of global regulatory procedures and a proven track record in leading the coordination and preparation of cross functional regulatory submissions across disciplinesAs such, the individual should possess a strong capability for entrepreneurial strategic thinking, collaboration, and flexibility with respect to developing non-traditional regulatory paths consistent with regulatory guidelines and regulations.
This role is based in waltham but is also suitable for a hybrid or remote work arrangement.
Providing key regulatory leadership in developing innovative regulatory approaches to small molecule and biologic product development in the oncology, cns, neuroscience, and rare disease space.
Providing senior management with critical risk assessments of the strategic alternatives for regulatory filings.
Providing strategic and operational regulatory direction and mentorship on projects including, but not limited to: regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and health authority interactions.
Reviewing sections of ind/cta, nda/bla/maa, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
Proactively managing critical regulatory issues, taking leadership for the regulatory strategy function.
Developing and implementing cross site department policies, processes and sops.
Building partnerships with key senior stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resources.
Supporting the planned growth and necessary changes of the alkermes organization through communication of company vision and strategy, business process improvement, relationship building, critical staffing, personnel growth and development.
Developing and growing the regulatory department in keeping with the needs of the company, as well as coaching and mentoring department staff.
Degree in a science field such as biology, chemistry, or pharmaceutical sciences.
Minimum of 14 years pharmaceutical/biotechnology industry experienceMinimum of 10 years in regulatory affairs.
Senior-level management of an approved new drug from development stages to market launch, and strong working experience directing the international clinical studies process.
Candidates must have proven strategic development capabilities related to new drug development and commercial support activities.
An extensive background and excellent relationship in working with the fda and global health authorities.
Oncology drug development / registration experience.
Must have superior leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies.
Good oral and written communications, time management, and team-oriented leadership skills are essential.
Alkermes, incIs 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, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal lawAlkermes also complies with all work authorization and employment eligibility verification requirements of the immigration and nationality act and ircaAlkermes is an e-verify employer.
Experience level: executive