Senior Manager, Regulatory CMC EMEA

at  Ultragenyx Pharmaceutical

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:

ultraimpact – Make a difference for those who need it most
Ultragenyx is seeking a highly motivated Senior Manager Regulatory CMC EMEA, who is inspired to be a compassionate leader in the field of drug development for rare disease patients. The Senior Manager 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 Senior Manager will report into the Senior Director Regulatory CMC EMEA and will be responsible for managing the regional regulatory CMC aspects of assigned projects, which may be in early to late-stage development, as well as maintenance and life cycle management of globally marketed products.
This position will support and manage regional regulatory activities for the EU and Middle East (EMEA) region 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.

REQUIREMENTS:

• BA/BS degree in life sciences in chemistry, molecular biology, or similar is required, an advanced degree is preferred.
• More than 6 years of experience in Regulatory Affairs CMC in the pharmaceutical and/or biotechnology industry. Alternatively, 4 years Regulatory CMC experience combined with more than 4 years relevant pharmaceutical experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance or Quality Control).
• Prior success filing of clinical trial applications, marketing applications, amendments, supplements, and variations for drugs and/or biologics within the EU is required; global submission experience and/or knowledge of global regulations/requirements is a desired plus.
• Thorough understanding of relevant drug development regulations and guidelines within the EMEA region 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.
• Travel: approximate 5% #LI-CK1 #LI-HYBRID

• Lead the development of regulatory strategies and interaction with Health Authorities with a focus on the EU and Middle East (EMEA) region; provide strategic input and regulatory advice to the project teams on clinical programs and life cycle management of marketed products.
• As a Regional Regulatory CMC representative to assigned program teams, collaborate with project teams to implement Ultragenyx regulatory strategies for the EMEA region. 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 or support the preparation and submission of regulatory applications (CTA, MAA, etc.) and any post-marketing commitments and maintenance. 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 or support the task of drafting responses to CMC related questions from health authorities per established process.
• Evaluate proposed manufacturing changes for regional impact to ongoing and existing dossiers and provide a regulatory assessment and a submission strategy for optimal implementation of changes.
• 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.