Associate Director, Regulatory Affairs

Associate Director Regulatory AffairsSumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs. The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff. This position works with a high level of autonomy and requires limited coaching and mentoring.Job Duties and ResponsibilitiesManage and Develop Talent + May train/mentor junior staffPhases I-IV Research & Development ActivitiesAs a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the productCompetent representation of GRA on project team meetingsLeads and coordinates project team members in developing strategy for applicable documents/activitiesPlans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submissionAssesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelinesLeads documentation of regulatory authority interactions including decisions and outcomesProvides updates at the Global Regulatory Team meetings and project teams as neededCollaborates effectively with regulatory operations leader (ROL)Maintains professional working relationship with colleagues, fostering collaboration, and idea sharingReviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as neededAdvises team members of major regulatory issues and provides possible solutions and leads the mitigation strategyLeads and coordinates local project team members in developing strategy for applicable documents/activitiesEnsures the quality and content of all submissions to Health AuthoritiesLeads the regional health authority meetings, liaison with local Health AuthorityDocument owner of briefing book documentation to Health AuthoritiesAssist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labelingAccountable in conjunction with the GRL as applicable for developing and maintaining the development core data sheet (DCDS) if requiredEnsure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global levelProvide strategic review of dossier summaries, expert statements, and development management plansProvide updates to the GRT, project teams, and governance boards as neededLeads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissionsMay be responsible for creating and reviewing SOPs and regulatory department operating proceduresKey Core CompetenciesStrong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills requiredUnquestionable ethics, professional integrity, and personal values consistent with the SMPA valuesAbility to work in a diverse environmentDemonstrated ability to adapt to changing priorities and work effectively in a matrix organizationDemonstrated ability to facilitate appropriate team decisionsSense of urgency and perseverance to achieve resultsExperience contributing to electronic regulatory submissions and working with regulatory templatesAdvanced understanding of medical terminology, and FDA and ICH regulations/guidance specific to clinical research and general product development in the pharmaceutical industryExperience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as neededUnderstands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solutionProven success/major involvement in NDA/MAA/CTD submissions and approvalCapable of effectively negotiating with others while maintaining composureDevelopment and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy documentAbility to learn new therapeutic areas when necessaryPrior history with post-marketing/brand optimization strategies and commercial awarenessExperience interacting with the FDA and ex-US Health AuthoritiesExperience in successfully leading teams and providing leadership in Health Authority negotiations and meetingsAbility to make complex decisions and willingness to defend difficult positionsComfortable presenting to all levels of the organization including Senior ManagementHigh degree of organizational awareness, ability to connect the dots to understand all the interdependency and big pictureEducation and ExperienceBachelor's degree in a related field required.Master's degree required (preferably in a scientific discipline)Approximately 7 years of prior biopharmaceutical or pharmaceutical industry experience; ideally with a minimum of 4 years focused in regulatory affairsThe base salary range for this role is $156,000 to $195,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.