Position: Executive

Job type: Full-time

Loading ...

Job content

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 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:If the role requires travel to the US or another country that requires evidence of covid vaccination for entry, candidates and employees will be required follow the local regulations and corporate policy regarding vaccination evidence submission.

Position Summary

The Vice President (VP), Head of Regulatory Affairs Europe is responsible for leading the European regulatory function and for building a regulatory infrastructure to ensure regulatory support in all European countries. The VP provides leadership and direction, including developing strategies to ensure successful achievement of regulatory objectives. The VP has oversight of allregulatory-related activities related to the launch of Ultragenyx commercial products in each of the Member States of the EU and for ensuring the implementation of post-marketing requirements following marketing authorization. In addition, the VP provides strategic input to guide development and registration plans to support successful approval of Ultragenyx products in Europe. The VP interfaces with European regulatory agencies, corporate partners and vendors. The VP also maintains awareness of the global regulatory environment and assesses/communicates impact of changes on business and product development programs. This position reports to the SVP, Global Head of Regulatory Affairs.

Responsibilities
  • Leads the European regulatory function and builds a regulatory infrastructure to ensure regulatory support in all European countries (initially using regional CROs and consultants as necessary)
  • Participates in the European leadership team and contributes to the plans for the region ensuring all regulatory requirements are met
  • Provides oversight of regulatory-related launch and post-marketing activities in the EU:
  • provides regulatory input to market access strategy and HTA plans and submissions in the EU
  • Ensures regional specific advice regarding post-marketing and promotional activities to legal, medical and regulatory review committees
  • Ensures promotional/disease awareness and internal training materials meet requirements of the applicable EU Directives and national regulations
  • Ensures product information is maintained in national databases
  • Ensures all packaging and labeling requirements are met according to local requirements
  • Ensures all post-marketing requirements and maintenance activities are met
  • Provides regulatory input for named patient sales/compassionate use programs in Europe
  • Provides regulatory leadership and strategic guidance regarding European requirements for development and registration of Ultragenyx products:
  • Acts as a bridge from the European Leadership team to the US Regulatory Affairs and the Development teams to ensure that Ultragenyx maximizes opportunities for European involvement in development activities
  • Serves as a key advisor regarding European requirements
  • Reviews key documents related to clinical development and registration of products and provide strategic input from a European regulatory perspective.
  • Leads discussions and meetings with European health authorities.
  • Influences the European regulatory environment
  • Identifies opportunities for influencing Health Authorities (via industry groups, regulatory network).
Requirements
  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
  • Specific requirements include but are not limited to:
  • At least 15 years of experience in European Regulatory Affairs in the pharmaceutical/biotechnology industry.
  • Bachelor of Science in a scientific discipline, MS or PhD preferred.
  • Rare disease/orphan product experience is desirable.
  • Strong knowledge of European regulations and requirements.
  • Strong strategic skills including demonstrated ability to make complex decisions and willingness to defend difficult positions.
  • Strong business acumen and demonstrated ability to make sound decisions that contribute positively to the business.
  • Strong team player that has a customer service approach and is solution oriented.
  • Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills.
  • Ability to prioritize and handle multiple projects simultaneously.
  • Business travel to be ~20% as required.
Management & Leadership Skills
  • Clarify Direction & Priorities: Set clear direction for your direct reports aligned with functional and corporate goals. Reprioritize work, as needed. Enable others to do their job well by communicating information and making decisions in a clear, timely manner.
  • Partner & Collaborate Effectively: Listen to and value others’ thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.
  • Support Learning & Growth: Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others.
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
  • Generous vacation time and public holidays observed by the company
  • Volunteer days
  • Long term incentive and Employee stock purchase plans or equivalent offerings
  • Employee wellbeing benefits
  • Fitness reimbursement
  • Tuition sponsoring
  • Professional development plans
  • Benefits vary by region and country
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.

See our CCPA Employee and Applicant Privacy Notice .

See our Privacy Policy .

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 .

Loading ...
Loading ...

Deadline: 05-05-2024

Click to apply for free candidate

Apply

Loading ...
Loading ...

SIMILAR JOBS