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Associate Director, Regulatory CMC
Location:
Woburn, MA
Description:
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 andpersonally, come join our team . Position Summary: ultra impact - Make a difference for those who need it most Ultragenyx is seeking a highly motivated Associate Director Regulatory Affairs CMC, who is inspired to be a compassionate leader in the field of drug development for rare disease patients. He/she is a curious learner, dedicated, highly focused, and welcomes unexpected challenges. The desired candidate must be a team player and enjoys a fast paced, dynamic work environment.The Associate Director will report into the Regulatory CMC group devoted to developing regulatory CMC strategies that support rapid development of products targeting rare and ultra-rare indications. He/she will be responsible for managing the regulatory CMC aspects of assigned projects in early to late-stage development, as well as maintenance and life cycle management of globally marketed products.This position will support and manage global regulatory activities associated with the Chemistry, Manufacturing and Controls for clinical and commercial products and provide input into the product strategy and to the direction provided to commercial and clinical teams. Work Model: 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. Responsibilities: Lead the development of regulatory strategies and interaction with global Health Authorities; provide strategic input and regulatory advice to the project teams on clinical programs and life cycle management of marketed products. As a Regulatory CMC representative to assigned program teams, collaborate with project teams to implement Ultragenyx regulatory strategies. Ensure and/or enhance regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle. Proactively identify project CMC issues and implement appropriate regulatory strategies to mitigate risks. Manage the preparation and submission of regulatory applications (IND/CTA, NDA/BLA/MAA, annual reports, etc.) and any post-marketing commitments. 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 submissions in a timely manner that supports agreed upon project timelines. Coordinate the task of drafting responses to CMC related questions from FDA/global health authorities per established process. Evaluate proposed manufacturing changes for global impact to ongoing and existing dossiers and provide a regulatory assessment and a submission strategy for optimal implementation of changes. Collaborate and provide support to Regulatory International for assigned program activities in the APAC region during 2022. Support the preparation and conduct of Agency meetings, including preparation and coordination of briefing packages. Support the organization in maintaining a 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 is required, an advanced degree is preferred. RAC certification desirable but not mandatory. 7 + years of experience in Regulatory Affairs CMC in the pharmaceutical and/or biotechnology industry. Alternatively, 6 years pharmaceutical Regulatory CMC experience combined with 4+ years relevant pharmaceutical experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance or Quality Control). Prior success filing clinical trial applications, marketing applications, amendments, supplements, and variations for drugs and/or biologics within timelines is required; global submission experience and/or knowledge of global regulations/requirements, e.g., APAC/LatAm, is a desired plus. Thorough understanding of relevant drug development regulations and guidelines 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 importance, providing regulatory advice and 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. #LI-CS1 #LI-Remote 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 XXXX@ultragenyx.com . See our CCPA Employee and Applicant Privacy Notice . See our Privacy Policy . 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 : XXXX@ultragenyx.com . PDN-9c6e59dd-92e7-40fb-9801-50944571026a
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More About this Listing: Associate Director, Regulatory CMC
Associate Director, Regulatory CMC is a Executive Associate Director Job at Ultragenyx located in Woburn MA. Find other listings like Associate Director, Regulatory CMC by searching Oodle for Executive Associate Director Jobs.
Associate Director, Regulatory CMC is a Executive Associate Director Job at Ultragenyx located in Woburn MA. Find other listings like Associate Director, Regulatory CMC by searching Oodle for Executive Associate Director Jobs.