Senior Manager Regulatory Affairs CMC, EMEA 12 month FTC

Why Join Us Be a hero for our rare disease patients At Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science applying a novel rapid development approach making innovative medicines at fair and reasonable prices and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives in and outside of we want to be an organization where we would be proud for our family friends and children to work. If you want to have a meaningful impact do the best work of your career and grow a lot both professionally andpersonally come join our team . Position Summary ultra dedicated Your biggest challenges yield rare possibilities Work Model Flex : This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite. This is a Fixed Term Contract for an initial period of 12 months. Responsibilities Lead the development of regulatory strategies and interaction with Health Authorities with a focus on the EU and Middle East (EMEA) region; provide strategic input and regulatory advice to the project teams on clinical programs and life cycle management of marketed products. As a Regional Regulatory CMC representative to assigned program teams collaborate with project teams to implement Ultragenyx regulatory strategies for the EMEA and / or enhance regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life CMC issues and implementappropriate regulatorystrategies to mitigate risks. Manage or support the preparation and submission of regulatory applications (CTA MAA etc.) and any post-marketing commitments and maintenance. Develop and / or review regulatory documents to ensure that all submissions are of high quality. Communicate with internal and external partners to obtain required supporting documents and data for compilation of regulatory submissionsin a timely mannerthat supports agreed upon project timelines. Coordinate or support the task of drafting responses to CMC related questions from health authorities per established process. Evaluate proposed manufacturing changes for regional impact to ongoing and existing dossiers and provide a regulatory assessment and a submission strategy foroptimalimplementation of changes. Support the preparation and conduct of Agency meetings including preparation and coordination of briefing packages. Support the organization inmaintaininga work environment focused on quality and that fosters learning open communication collaboration integration and teamwork. Requirements BA / BS degree in life sciences in chemistry molecular biology or similar isrequired an advanced degree is preferred. More than6years of experience in Regulatory Affairs CMC in the pharmaceutical and / or biotechnology industry. Alternatively 4 years Regulatory CMC experience combined with more than 4 years relevant pharmaceutical experience (e.g. Pharmaceutical Development Analytical Development Production Quality Assurance or Quality Control). Prior success filing of clinical trial applications marketing applications amendments supplements and variations for drugs and / or biologics within the EMEA region isrequired; global submission experience and / or knowledge of global regulations / requirements is a desired plus. Thoroughunderstanding of relevant drug development regulations and guidelines within the EMEA region is essential to support programs during development and commercial lifecycle. Proven ability to successfully interact with regulatory authorities. Working knowledge in the rare disease space and the ability to deal with issues of critical importanceprovidingregulatoryadviceand making reasoned decisions on regulatory issues for which there may not be clear / specific regulatory guidance is privileged. Understanding of scientific principles and regulatory CMC requirements relevant to all stages of pharmaceutical drug development and manufacturing process validation analytical operations compliance and documentation supported by a strong quality mindset. Travel : approximate 5% Fluent in English Arabic is a plus #LI-CT1 #LI-Hybrid Benefits Generous vacation time and public holidays observed by the company Volunteer days Long term incentive and Employee stock purchase plans or equivalent offerings Employee wellbeing benefits Fitness reimbursement Tuition sponsoring Benefits vary by region and country Professional development plans Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type: Full Time Experience: years Vacancy: 1 Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity / expression national origin / ancestry age disability marital and veteran status and any other status or classification protected by applicable federal state and / or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law including individuals with disabilities disabled veterans for pregnancy childbirth and related medical conditions and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or in any part of the recruitment process you may contact Talent Acquisition by emailing us at . See our CCPA Employee and Applicant Privacy Notice. See our . 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. Note to External Recruiters : All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees / hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to : . Required Experience: Senior Manager Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills #J-18808-Ljbffr