- Lead the Regulatory CMC function to support the CMC portfolio goals with proven track record of successfully building and leading teams.
- Lead global CMC regulatory strategies for projects in development and marketed products, including risk mitigation strategies to ensure approvals and maintenance of product licenses.
- Strengthen internal gene therapy CMC capability by working with internal stakeholders and external partners to evaluate and enable gene therapy related GTP/GMP facility
- Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
- Exercise expertise in the interpretation and implementation of ICH guidelines with a goal of an approved/ harmonized regulatory control strategy.
- Ensure regulatory conformance & consistency for assigned products globally in compliance with regulatory requirements and internal procedures.
- Partner across the CMC functions in the company, and other functional groups at Ultragenyx to support opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
- Develop meaningful and collaborative relationships with local & global internal/ external partners.
- Demonstrate success in influencing without positional authority within a highly matrixed organization.
- A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD.
- Demonstrated organizational leadership skills at both functional and enterprise levels.
- Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions.
- Application of sound and accurate judgment to make timely decisions.
- Gene Therapy experience is preferable.
- Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.).
- Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
- Excellent strategic acumen, collaboration, and communication skills are required. #LI-CS1 #LI-Hybrid
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Vice President, Regulatory Affairs, CMC - Somerville, United States - Ultragenyx
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 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 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:
ultrafocused - Work together to fearlessly uncover new possibilities
The Vice President of CMC Regulatory Affairs is leading the Ultragenyxs CMC Regulatory Affairs function. Ultragenyx have an exciting portfolio with both marketed, late and early-stage projects across Gene Therapy, Biologics and small molecules for Rare Diseases.
This position is a key strategic role ensuring regulatory strategies supports global approvals and maintains our global licenses across North America, Europe, Latin America and Japan. In addition, the leader will be recognized as a global thought leader for regulatory science and be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions. The leader will also be responsible for ensuring that regulatory strategy is deeply integrated into Pharmaceutical Development & Manufacturing (PDM) project teams and overall goals. The role will report directly to Senior Vice President of Regulatory Affairs at Ultragenyx.
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:
Requirements:
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 applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
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
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: .PDN-9bf5a cc d4dd916f229
