Director, Regulatory Affairs Brazil

<div class="content-intro"><div><strong>Why Join Us?</strong></div> <div> </div> <div><em>Be a hero for our rare disease patients</em></div> <div><em> </em></div> <div>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 do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t 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. </div> <div> </div> <div>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 work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.</div> <div> </div> <div>If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team<em>. </em></div></div><h3 style="text-align: left;"><strong>Position Summary:</strong></h3> <p style="text-align: left;"><strong><em>ultra</em></strong><em>focused – Work together to fearlessly uncover new possibilities</em></p> <p style="text-align: left;"><span class="TextRun SCXW75123422 BCX8" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW75123422 BCX8">Ultragenyx is </span><span class="NormalTextRun SCXW75123422 BCX8">seeking</span><span class="NormalTextRun SCXW75123422 BCX8"> an experienced and highly motivated Director</span><span class="NormalTextRun SCXW75123422 BCX8">, Regulatory Affairs</span><span class="NormalTextRun SCXW75123422 BCX8"> Brazil</span><span class="NormalTextRun SCXW75123422 BCX8"> </span><span class="NormalTextRun SCXW75123422 BCX8">who is a</span><span class="NormalTextRun SCXW75123422 BCX8"> team player </span><span class="NormalTextRun SCXW75123422 BCX8">and thrives in a </span><span class="NormalTextRun SCXW75123422 BCX8">fast</span><span class="NormalTextRun SCXW75123422 BCX8">-</span><span class="NormalTextRun SCXW75123422 BCX8">paced</span><span class="NormalTextRun SCXW75123422 BCX8">, dynamic work environment. </span><span class="NormalTextRun SCXW75123422 BCX8">The Director will </span><span class="NormalTextRun SCXW75123422 BCX8">be responsible for</span><span class="NormalTextRun SCXW75123422 BCX8"> developing key regulatory strategies and </span><span class="NormalTextRun SCXW75123422 BCX8">lead</span><span class="NormalTextRun SCXW75123422 BCX8"> the execution of </span><span class="NormalTextRun SCXW75123422 BCX8">submissions </span><span class="NormalTextRun SCXW75123422 BCX8">in Brazil </span><span class="NormalTextRun SCXW75123422 BCX8">while </span><span class="NormalTextRun SCXW75123422 BCX8">monitoring</span><span class="NormalTextRun SCXW75123422 BCX8"> and assessing </span><span class="NormalTextRun SCXW75123422 BCX8">applicable</span><span class="NormalTextRun SCXW75123422 BCX8"> regulations including Gene Therapy guidance and regulation changes. </span><span class="NormalTextRun SCXW75123422 BCX8">The Director will work closely with regional and global </span><span class="NormalTextRun SCXW75123422 BCX8">regulatory colleagues, functional areas, and project teams to support regulatory activities in </span><span class="NormalTextRun SCXW75123422 BCX8">Brazil as a key market in </span><span class="NormalTextRun SCXW75123422 BCX8">the </span><span class="NormalTextRun SCXW75123422 BCX8">Latin America</span><span class="NormalTextRun SCXW75123422 BCX8"> region</span><span class="NormalTextRun SCXW75123422 BCX8">. The </span><span class="NormalTextRun SCXW75123422 BCX8">Director</span><span class="NormalTextRun SCXW75123422 BCX8">, Regulatory Affairs </span><span class="NormalTextRun SCXW75123422 BCX8">Brazil</span><span class="NormalTextRun SCXW75123422 BCX8"> will be based </span><span class="NormalTextRun SCXW75123422 BCX8">in Sao Paulo</span><span class="NormalTextRun SCXW75123422 BCX8">, </span><span class="NormalTextRun SCXW75123422 BCX8">Brazil</span><span class="NormalTextRun SCXW75123422 BCX8"> with hybrid model requiring some office-days</span><span class="NormalTextRun SCXW75123422 BCX8">.</span><span class="NormalTextRun SCXW75123422 BCX8"> </span><span class="NormalTextRun SCXW75123422 BCX8">The position will report to the Senior Director</span><span class="NormalTextRun SCXW75123422 BCX8">, Regulatory </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW75123422 BCX8">Affairs</span><span class="NormalTextRun SCXW75123422 BCX8"> LATAM.</span></span><span class="EOP SCXW75123422 BCX8" data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <h3 style="text-align: left;"><strong>Work Model: </strong></h3> <p style="text-align: left;">Flex: This role will typically require onsite work 2-3 days each week or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.</p> <h3 style="text-align: left;"><strong>Responsibilities:</strong></h3> <ol> <li style="line-height: 2;"><span data-contrast="none">Be responsible for all Regulatory Affairs strategies for the portfolio and pipeline in Brazil.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Provides strategic and technical input on regulatory requirements to development teams, at regulatory sub teams and to leadership.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Lead assessments of Life Cycle Management changes to provide strategic guidance and expert support to global teams by applying technical knowledge, experience and creative solutions.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Leads all planning, preparation, and execution of regulatory interactions with ANVISA and other agencies in Brazil for select programs.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Represent Brazil Regulatory in sub team meetings, serving as the point of contact for the assigned products, and interfacing with functional areas including Research, Development and Clinical in strategic development for late-stage products.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Oversees submission processes and leads major applications in Brazil (e.g. MAAs, CTAs, LCM, GMPc).</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Lead regulatory partnerships with key stakeholders to deliver innovative strategies, facilitating interactions with local partners/consultants.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Manage preparation of responses to questions to ANSIVA and/or any health authorities in Brazil as well as prepare comments on draft documentation sent out for consultation from the health authority.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Develop and implement regulatory policies, processes, and SOP in Brazil in compliance with Ultragenyx SOPs.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Creates, coordinates and maintains submission schedules and timelines with regulatory operations and the cross functional team, ensuring timely delivery of high-quality documents.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Keep current with Brazil and relevant Agency guidelines and regulations.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Act as Pharmacovigilance (PV) Deputy in the absence of the Brazilian Pharmacovigilance Responsible, where all PV responsibilities will be delegated to the deputy through a documented handover process.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Contribute to creation of local labels as needed.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Be regulatory partner and lead contribution in Veeva PromoMats process as needed.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Provides supervision and mentoring to junior regulatory professionals on the team, if applicable.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Participate in cross-functional committees and sub-teams in accordance with company initiatives, as necessary.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Strategic participation in trade associations meetings such as SINDUSFARMA is required.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240}"> </span></li> </ol> <h3 style="text-align: left;"><strong>Requirements:</strong></h3> <ol> <li style="line-height: 2;"><span data-contrast="none">Pharmacy degree preferred or BA/BS degree in life sciences and 10 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry. Advanced degree preferred​.</span><span data-ccp-props="{"201341983":2,"335559739":75,"335559740":270}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">The candidate must have hands on experience for at least 5 years with regulatory filings biologics/biotech and specialized therapies in Brazil, as well as preferred experience with Gene Therapies and other compounds for the treatment of rare diseases.</span><span data-ccp-props="{"201341983":2,"335559739":75,"335559740":270}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">In depth understanding and application of industry standards and international/ ANVISA regulations and guidelines for MAA/CTAs/LCM drug registration processes. </span><span data-ccp-props="{"201341983":2,"335559739":75,"335559740":270}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Sound knowledge of global regulatory framework, drug development and post approval requirements including foreign regulations and WHO/ICH is required. </span><span data-ccp-props="{"201341983":2,"335559739":75,"335559740":270}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Experience working with high effectiveness and building strong partnerships with key internal and external stakeholders.</span><span data-ccp-props="{"201341983":2,"335559739":75,"335559740":270}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Experience in communicating regulatory strategy, submission documents and plans both internally and externally.</span><span data-ccp-props="{"201341983":2,"335559739":75,"335559740":270}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">The desire and ability to work in a fast-paced, start-up environment, eager to learn/apply new skills.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li> <li style="line-height: 2;"><span data-contrast="none">Requires initiative, able to work independently, creative problem-solving ability, hands-on willing to work, and excellent verbal and written communication skills in Portuguese and English. Spanish is a plus.</span><span data-ccp-props="{"201341983":2,"335559739":75,"335559740":270}"> Please complete your application and submit your CV in English. </span></li> <li style="line-height: 2;"><span data-contrast="none">Demonstrated ability to strategize, prioritize, contribute to decision-making and manage with project management skills multiple tasks simultaneously.</span></li> </ol> <p><span style="color: rgb(255, 255, 255);"><strong><span class="ui-provider wf b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak">#<span style="color: rgb(255, 255, 255);">LI-CT1 #LI-Hybrid</span></span></strong></span></p><div class="content-conclusion"><div> </div> <div><strong><em>Full Time employees across the globe enjoy a range of benefits, including, but not limited to:</em></strong></div> <div> </div> <div><strong><em>·         Generous vacation time and public holidays observed by the company</em></strong></div> <div><strong><em>·         Volunteer days</em></strong></div> <div><strong><em>·         Long term incentive and Employee stock purchase plans or equivalent offerings</em></strong></div> <div><strong><em>·         Employee wellbeing benefits</em></strong></div> <div><strong><em>·         Fitness reimbursement</em></strong></div> <div><strong><em>·         Tuition sponsoring</em></strong></div> <div><strong><em>·         Professional development plans</em></strong></div> <div> </div> <div><em>* Benefits vary by region and country</em></div> <div> <p><strong>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 </strong><a href="mailto:talentacquisition@ultragenyx.com"><strong>talentacquisition@ultragenyx.com</strong></a><strong>.</strong></p> </div> <div><em>See our </em><a class="postings-link" href="https://www.ultragenyx.com/CCPA-Notice/"><em>CCPA Employee and Applicant Privacy Notice</em></a><em>.</em></div> <div><em>See our </em><a class="postings-link" href="https://www.ultragenyx.com/privacy-policy/">Privacy Policy</a><em>.</em></div> <div> <p><strong>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.</strong></p> </div> <div><strong>Note to External Recruiters</strong>: 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<em>: </em><a class="postings-link" href="http://mailto:talentacquisition@ultragenyx.com/">talentacquisition@ultragenyx.com</a><em>.</em></div></div>