Director, Regulatory Affairs

Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site.In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number.We look forward to discovering your talents.Welcome to an inspired career.At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team – we rise by lifting others up and believe in the power of working together for the collective win. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.Join us as a Director, Regulatory Affairs , and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives.How you will make an impactThe Director, Regulatory Affairs leads in the co-development and implementation of global regulatory strategies for marketed and development products. They lead regulatory activities for internal and external programs and work closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of global regulatory filings for external collaboration Partners. The role is expected to exhibit strong organizational leadership and values while influencing the future direction of Halozyme Therapeutics and its partners.In this role, you’ll have the opportunity to:Provide strategic regulatory leadership and direction to product teams addressing the regulatory requirements for quality submissions, clarifying requirements for appropriate CMC controls, and maintaining forecasted timelines in support of the overall programsProvide strategic regulatory leadership and guidance to internal project teams and external collaboration Partner teams for chemistry, manufacturing, and controls (CMC) sections intended to support IND/CTA and BLA submissions.Interacts with multiple partners communicating with domestic and foreign regulatory agencies and directly with regulatory agenciesProvide leadership and mentorship for major changes to the supply network, including but not limited to: site-to-site technical transfers, QC transfers, new product development and implementing comparability protocols on a strategic basisServe as a liaison among the company, partners, and regulatory authorities on regulatory issuesAdvise on the tactics and strategies for mitigating regulatory risksLead regulatory partnership programs to ensure overall clinical and commercial regulatory strategy is achievedMaintain up-to-date knowledge and expertise of relevant FDA, EMA, PMDA, ICH, WHO and other applicable guidelines and regulationsFacilitate timely regulatory approvals for partners’ clinical trial applications, marketing applications and post-approval life-cycle management amendments/supplements by ensuring the quality and appropriateness of submissionsLead cross-functional teams for timely preparation of high-quality regulatory submissions and responses to inquiries including CMC sections for partners’ initial applications, amendments/supplements, and response documents for regulatory agenciesEvaluate chemistry, manufacturing, and controls (CMC) change control records, assess regulatory impact, and support change implementationSupport budget and resource planning initiatives for regulatory activities as neededSupervise, mentor, train and develop regulatory professionals supporting the assigned program(s) in a manner that blends the organizational needs with their developmental needs.Identifies priorities and key issues in complex situations and solves these problems with minimal assistanceProvides preparation and planning support for meetings with regulatory agenciesRoutinely interacts with Halozyme external partners to assure timely development of strategies, deliver required regulatory support and craft high-quality submissionsWork closely with the R&D, Product Development, Manufacturing, Quality, and Preclinical Development departments, Contract Development and Manufacturing Organizations (CDMOs), and experts in Halozyme external partners’ organizationsAcknowledge and assess gaps in information, process as they arise, and develop solutions to fill/mitigate those gapsOther duties as assignedTo succeed in this role, you’ll need:BS/BA in a scientific discipline with 10 years of industry experience, or MS degree with 6 years’ experience, or equivalent combination of education/experience will be considered.A minimum of 8 years in regulatory affairs disciplinesAt least 5 years’ experience in a regulatory affairs management position in a biotech or pharmaceutical company involved in the development, manufacture, testing and distribution of ethical pharmaceutical products or biotechnology productsDemonstrated leadership in developing and implementing regulatory strategy and experience in regulatory interactionsAbility to prioritize and lead sophisticated projects, timelines and teams in a matrix team environmentCreative approach to problem solving; ability to deal with ambiguity and perform the necessary research to define a clear path forwardDemonstrated track record of being results drivenStrong leader who works through the team to prioritize and drive achievementsStrong oral and excellent written communication skillsEnergetic person with ability to prioritize and work on multiple projects at the same timeStrong business acumen, with the ability to balance business and staff development needsExperience in the preparation and submission of: INDs, CTAs, BLAs, MAAs, Annual Reports, Amendments, and/or SupplementsFamiliarity with regulatory aspects combination drugs/devices desiredKnowledge of cGMPs, GCPs, and global CMC regulations pertaining to the development, manufacturing and distribution of biologics or drugs; familiarity with global regulatory guidelines and standards; significant experience dealing with regulatory authoritiesIndustry certification such as Regulatory Affairs Certification (e.g., RAC-Drugs) desiredSoftware Knowledge: Windows OS, MS Office Suite (Outlook, Word, Excel), Adobe, Veeva RIM, MasterControl, SharePoint, etc.In return, we offer you:Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.The most likely base pay range for this position is $215K - $230K per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.Accessibility and Reasonable Accommodations:Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at View email address on click.appcast.io .To view all our open positions, please visit our career page . Additionally, our benefit offerings can be found here #J-18808-Ljbffr Halozyme,-Inc.-1