Director, Regulatory Affairs, Europe

vor 1 Tag

Allschwil, Schweiz Ultragenyx Pharmaceutical Inc. Vollzeit

**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. _
- _
- Roles based outside the US:_

Position summary

**_ ultradedicated - Your biggest challenges yield rare possibilities_**

The Associate Director, Regulatory Affairs 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 Europeand manages EU regulatory objectives in support of the development, registration and life-cycle management of innovative programs for rare diseases in alignment with department and corporate goals. He/she will work closely with cross-functional project teams to support product development, global clinical trials and marketing approvals, while ensuring that regulatory strategies are implemented and requirements for the assigned projects are achieved. The Associate Director Regulatory Affairs EU will be assigned projects in the Ultragenyx product portfolio depending on the business need. The Associate Director should have regulatory experience of managing early and late stage products particularly in the EU. The individual must possess a thorough knowledge of Global and European rules, regulations, and guidances governing drugs, biologics in all phases of development. The individual will provide oversight of the content and preparation of all regulatory documents/submissions related to applicable programs of the regulatory team. Strong communication and management skills are required. The position reports to the Director/Senior Director Regulatory Affairs.

**What you will be doing**:

- Develop regulatory strategies, particularly for region Europe and proactively identify project issues and propose appropriate regulatory strategies to mitigate risks.
- Manage and lead 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, non-clinical 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.
- 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 in creating and maintaining an EU reporting dashboard for teams and management.
- Ensure accurate retention of all regulatory submission and contacts with health authorities in the archival system.
- Lead or contribute as required to the development of department projects, processes, SOPs etc. to support regional and local processes.

**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 (6) years of experience in Regulatory Affairs i

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