Position: Director

Job type: Full-time

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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. During the COVID-19 Outbreak, we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.

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. During the COVID-19 Outbreak, we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.

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. During the COVID-19 Outbreak, we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.

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. During the COVID-19 Outbreak, we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.

Position Summary

ultracurious – Apply your biggest ideas in courageous ways

As Director, Regulatory Affairs, you guide optimal EU regulatory strategies for assigned products during product development and manage EU regulatory goals (nonclinical, clinical, CMC) with department and corporate goals. You work with project teams to support product development, global clinical trials and marketing approvals, while ensuring that EU regulatory strategies are implemented and EU requirements for the assigned projects are achieved. You have thorough knowledge of European rules, regulations, and guidance governing drugs, biologics and ATMPs (e.g. gene therapy) in all phases of development. You report to the Vice President, Head of Regulatory Affairs Europe.

This role can be based in Basel, Switzerland. We will also consider remote candidates.

Your Responsibilities Include
    • Develop and lead regulatory strategies to maximize the likelihood of regulatory success in Europe and to support the global program development plan
    • Provide proactively tactical guidance and regulatory support to teams and corporate partners to ensure timely and efficient conduct of development programs
    • Plan/oversee/prepare essential European regulatory documents (briefing documents) to support central and national advice, Orphan Drug Designations, Pediatric Investigation Plans Marketing Authorisation Applications while ensuring consistency with EU regulatory requirements and the global regulatory program strategy
    • Proactively identify program issues and support to implement appropriate regulatory strategies to mitigate risks
    • Function as primary liaison with regulatory authorities, affiliates and consultants
    • Strategically plan, prepare, and implement meetings and teleconferences with regulatory authorities
    • Oversee the development of high-quality submissions and responses to regulatory authorities, including meeting materials, amendments, and annual reports
    • Provide guidance to clinical study teams as applicable to ensure EU regulatory requirements are met and that the clinical trial meets EU program development goals and timelines
    • Provide EU regulatory expertise to the global regulatory team to develop the regulatory program strategy and submission plan
    • Approve applicable promotional/disease awareness materials
    • Ensure accurate retention of all regulatory submission and contacts with health authorities in the archival system
    • Maintain knowledge of and monitor changes in current European rules, regulations, and guidances governing drugs, biologics and ATMPs in all phases of development, and knowledge of therapeutic area(s)
    • Lead or contribute to the development of SOPs to support regional and local processes

What You Bring To The Role
    • BA/BS degree in life sciences or experience in drug development that allows for sufficient knowledge in this area. Advanced degree preferred
    • Strong scientific background with at least eight (8) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries
    • Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies
    • Work independently and in a team environment, with strong leadership, negotiation and influencing ability
    • Thorough understanding of European 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
    • Experience with development of drugs/biologics/ATMPs for rare diseases is preferred Excellent attention to detail with solid coordinating, task planning and time management skills
    • Outstanding verbal, written and interpersonal communication skills
    • Proficient use of Office 365, cloud-based and virtual collaboration tools expected (MS Office tools, EDMS, Internet resources, Zoom, OneDrive)
    • Languages: fluent English, other European languages are a plus
    • Travel requirements approx. 10% (more if located outside of Switzerland)

Applications and CV’s to be submitted in English. Eligible applicants are in possession of a valid work permit.

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us attalentacquisition@ultragenyx.com . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

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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 .

Allschwil, Switzerland /

Ultragenyx – Regulatory Affairs /

Full-time

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Deadline: 10-05-2024

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