Job DescriptionSenior Regulatory Affairs ManagerThe Senior Regulatory Affairs Manager manages assigned regulatory and cross-functional projects; provides strategic and operational support to Veristat clients in regulatory decision-making processes, filings and maintenance of healthcare products and plays a key role in providing consultation to Veristat's clients, in translating regulatory requirements into practical application to ensure the success of clinical trials and regulatory submissions. S/he will work with project teams, provide advice on regulatory agency interactions, manage agency communications, support the preparation of submissions, and create strong rapport with clients.Make an Impact at VeristatJoin a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.105+ approved therapies for marketing applications prepared by Veristat480+ oncology projects in the past 5 years350+ rare disease projects delivered in the past 5 yearsFlexible, inclusive culture — 70% remote workforce, 66% women-led teamsLearn more about our core values hereWhat We OfferBenefits vary by location and may include:Remote workingFlexible time offPaid holidaysMedical insuranceTuition reimbursementRetirement plansWhat We Look ForBachelor's degree in a related field required. Advanced scientific degree (i.e. PhD or Master's degree) preferred.6 - 8 years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting (or demonstrated ability to function at this level), with a proven track record of global regulatory submissionsAs Senior Manager Regulatory Affairs CMC: familiar with manufacturing, specifications, analytical testing and overall regulatory CMC requirementsThorough knowledge of International Conference on Harmonisation (ICH) guidelines and regulatory guidelines in the relevant territories as well as drug development, clinical trials, and clinical researchExcellent written and oral communication skills including grammatical/technical writing skills, and familiarity with drug development, agency interactions, study designs and regulatory requirements that apply to clinical trials are requiredDemonstrated ability to develop and foster positive client relationships.Demonstrated ability to lead by example and demonstrated skill for technical leadership of staff.Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.