Manager, Global Regulatory Strategy at Ultragenyx Pharmaceutical

United States

$132.4k - $163.6k

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 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. 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. 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. Position Summary: ultrainnovative – Tackle rare and dynamic challenges The Manager, Global Regulatory Strategy will be responsible for managing clinical and nonclinical regulatory aspects of assigned program(s). The responsibilities include working closely with functional areas and project teams to support product development and approval. The individual must possess a thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development. Strong communication and management skills are required. The position level is dependent on experience and qualifications. Work Model: Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed. Responsibilities: Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met. Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development program. Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks. Develop and/or review regulatory documents to ensure that all submissions are of high quality. Provide critical review of documents (SOPs, protocols, and reports) related to clinical, nonclinical or manufacturing, as necessary. Interface with functional areas (Nonclinical, Clinical, Commercial) to identify and obtain information required for regulatory submissions. Prepare/coordinate/file/manage IND/CTAs, annual reports, and information amendments in multiple countries for multiple protocols. Prepare/coordinate/file/manage regulatory applications (IND/CTA, NDA/BLA/MAA). Interface with global regulatory authorities and consultants. Coordinate, prepare for and conduct Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages. Maintain knowledge of current global rules, regulations, and guidances governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area. Requirements: BA/BS degree in life sciences or experience in drug development that allows for sufficient knowledge in this area. Strong scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries. Prior experience with product development in a project management role with relevance to early phase non-clinical and clinical drug development. Excellent attention to detail with solid coordinating, task planning and time management skills. Outstanding verbal, written and interpersonal communication skills. Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability. Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies. Thorough understanding of global drug development regulations and guidelines. Proven ability to successfully manage major submissions and critical projects to deadlines. Proven ability to successfully interact with regulatory authorities. #LI-CS1 #LI-Remote The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment. Pay Range $132,400—$163,600 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · 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 · Professional development plans * Benefits vary by region and country 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 talentacquisition@ultragenyx.com. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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: talentacquisition@ultragenyx.com.