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Associate Director Regulatory Affairs, Cmc
vor 2 Wochen
**Why Join Us?**
- Be a hero for our rare disease patients_
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_. During the COVID-19 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing._
- US based roles:_ Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.
- **Position Summary**
**ultraimpact** - 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. You are a curious learner, dedicated, highly focused, and welcomes unexpected challenges. Additionally, you are be a team player and thrive in a fast paced, dynamic work environment.
In this role, you report into the Regulatory CMC group devoted to developing regulatory CMC strategies that support rapid development of products targeting rare and ultra-rare indications. You are 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.
In this position, you 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: can complete work from home during the pandemic; once return to the office 2-3 days in office to be expected and established with manager
**What you will be doing**:
- 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.
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.
- 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.
**What you bring to the role**:
- 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.
- 10 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).
Thorough understanding of relevant drug development regulations and guidelines is essential to support programs during development and commercial lifecycle. Proven ability to successf
