Job Detail

Senior Manager Regulatory Affairs (Switzerland or Remote EU/EFTA)

Allschwil, Switzerland /Ultragenyx – Regulatory Affairs /Full-timeApply for this jobWhy 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.

Who We’re looking for?Generous and Candid. You treat everyone with respect and communicate broadly and often - providing clear purpose, context, necessary information, candid feedback and business insights that helps to propel your colleagues and stakeholders forward.Courageous and Drive Results. You are resilient, resourceful, roll up your sleeves, and challenge the status quo.  You are a servant leader - passionate about our patients, the business, never compromising relationships.Relentless, Culture and Patient Focused.  You are driven by a deep commitment to delivering treatment to our patients.  You are relentless about making a difference to patients and their families. Dynamic and Fiercely Collaborative. You are a catalyst for innovation, you partner closely with your peers to drive Regulatory Affairs partnership activities, and you’re invested in others' success. You're purposefully inclusive and are a role model for stakeholder management.Creative and See Possibility.  You think strategically and explore multiple ways to deliver unique value to the business. You are known not only for your skills of diagnosing organizational needs, but more importantly you have great ideas and you can influence action to be taken that address those needs.  You are someone who thrives in the building and creation stage of an organization—taking your insights to action

Position Summaryultrainnovative – Tackle rare and dynamic challenges

As Senior Manager, Regulatory Affairs Europe, you will be responsible for managing for all regulatory aspects (nonclinical, clinical, CMC) of a program at any stage of a product (clinical, and maintenance) for region Europe for the assigned product(s). Responsibilities include working closely with cross functional teams to prepare regulatory submission timelines and co-ordinate submission content, preparing some components as appropriate, and managing the overall submission process including review and approval process in close collaboration with the global Regulatory Affairs team, as well as functions both in region Europe and head offices in California. You possess good knowledge of rules, regulations, and guidance governing drugs and biologics in all phases of development, particularly in Europe.

Your responsibilities include:

• Prepare/coordinate/file/manage all regulatory applications and submissions (CTAs, ODDs, MAAs, amendments, variations and others) as required in region Europe. Ensure submissions are complete and are of high quality


• Manage preparation of responses to questions from Regulatory Authorities


• Develop and/or provide critical review of documents (e.g protocols, reports, responses to Health Authority questions, SOPs) related to clinical, nonclinical or manufacturing, as necessary


• Create and maintain regulatory submission timelines and tracking deliverables to ensure milestones are met


• Interface with functional areas (CMC, Nonclinical, Clinical, Commercial) to identify and obtain information required for regulatory submissions


• Contribute to the development of regulatory strategies, particularly for region Europe


• Proactively identify project issues and propose appropriate regulatory strategies to mitigate risks


• Provide regulatory support related to the maintenance of commercial products in Europe including updates to labeling and packaging, and assisting with the review of promotional/disease awareness and internal training materials


• Support maintenance of product information and other documentation in national databases


• Participate in Regulatory Affairs sub-team meetings providing input on development strategy and submission timelines to support EU regulatory goals


• Interface with global regulatory authorities and consultants as needed


• Support the preparation and conduct of Health Authority meetings, as necessary to support regulatory filings and applications, including the preparation and coordination of briefing packages


• Support in creating and maintaining an EU reporting dashboard for teams and management


• Contribute or lead regulatory projects including EU regulatory research as needed


• Contribute as required to the development of SOP’s to support regional and local processes


• Coordinate with external service providers and keep regulatory spending overview up-to date


• Maintain knowledge of current European regulations and guidances governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area

What you bring to the role:

• BS/MS in a science field required; PhD degree preferred; Regulatory Science program preferred


• Strong scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry


• Proven ability to successfully manage major submissions and critical projects to deadlines


• Thorough understanding of global drug/biologics regulation, particularly in Europe


• Prior experience with development of regulatory strategies for the EU and/or any major submissions e.g. MAA, Type II variation.


• Demonstrated understanding of European drug development regulations and guidelines; Knowledge of foreign regulations and ICH is a plus.


• Knowledge of orphan drug development is a plus.


• Knowledge of biologics requirements is a plus.


• Excellent organizational skills with attention to detail, solid coordinating, task planning and time management skills


• Outstanding verbal, written and interpersonal communication skills


• Work independently and in a team environment, with strong leadership, negotiation and influencing ability


• Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making and implementing plans and risk mitigation strategies


• 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)

Submit applications and CV's in English, applicants are in possession of valid working permits for the country of their residence.

#LI-CG1#LI-Remote

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 at talentacquisition@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.

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