Associate Director Regulatory Affairs Fixed Term Contract

Job description

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:

ultra innovative – Tackle rare and dynamic challenges

As our Associate Director, Regulatory Affairs EMEA, you drive optimal EMEA regulatory strategies for assigned products during product development and manage EMEA regulatory objectives (nonclinical, clinical) in alignment with department and corporate goals. You work closely with cross functional project teams to support product development, global clinical trialsand marketing approvals, while ensuring that EMEA regulatory strategies are implemented and EMEA requirements for the assigned projects are achieved. You will initially be focusing on some of Ultragenyxmarketed/pipeline programs and the respective regulatory strategies including their execution. You possessappropriate knowledgeof EMEA rules, regulations, and guidance governing drugs, biologics and ATMPs (e.g.gene therapy) in late phases of development and post-marketing. Strong communicationskills are required.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Provides strategic and technical input on regulatory requirements to development teams
2. Participates in regulatory strategy development and executes the strategy
3. Provides input on development plans
4. Reviews regulatory documents
5. Coordinates sections of major applications (IND, NDA, BLA, MAA etc)
6. Assists in preparing label text
7. Tracks PMCs/PMRs
8. May be Primary liaison with Regulatory Agencies
9. Manages planning, preparation and execution of agency meetings
10. Leads Agency response processes
11. Manage the coordination between global and local regulatory partners

Requirements:

1. Minimum BS/BA in life sciences
2. Advanced degree preferred
3. At least 8 years regulatory experience
4. Sound knowledge of global regulatory framework, drug development and post approval requirements
5. Specific knowledge and experience of the regulatory requirements in the GCC region is required
6. Travel requirements less than 10%
7. Fluent in English, Arabic is a plus
8. This position can be located either in UK, Switzerland or Dubai (Applicants must be in possession of a valid work permit for the location)

#LI-CK1 #LI-Hybrid, #LI-Remote

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 and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected] .

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 : [email protected] .