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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont 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 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.
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
Ultragenyx is seeking an experienced and highly motivatedAssociateDirector Regulatory Affairs (Clinical/Nonclinical Strategy)EMEAwho is a teamplayer and enjoys a fast paced dynamic work environment. TheAssociateDirector will beresponsible for developing keyEMEAregulatory strategies and executing submissions while monitoring and assessingEMEAregulations including GeneTherapyguidance and regulation changes.This position will report to theSenior Director Regulatory Affairs EMEA.
Work Model:
Flex: This role will typically require onsite work 2 days each week depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Interfaces with EMEA regulatory agencies as appropriateonselect programs.
- Independently research options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership.
- RepresentEMEARegulatory in sub team meetings serving as the point of contact for the assigned productsin the EMEA region and interfacing with functional areas including Research Development and Clinical in strategic development for early and late-stage products.
- Provideregulatory guidancefor the EMEA regionand input throughout product development to theregulatory subteam.
- Lead cross functional teams in EMEA Regulatory Filings ( GMOs MAAs)
- Lead selects Regulatory vendor meetings in alignment with product programs and Regulatory-driven projects
- MaintainCTAs ensuring Agency compliance
- Review clinical documentation including protocols DSURs Investigator Brochures Investigator Packages and General Investigational Plans to ensure GCP and Agency compliance
- Lead teams in the development of briefing documents for EMEA Agency meetings
- Manage and direct contractors/vendors as needed on programs
- Keep current with EMEA Agency guidelines and regulations
- Prepare comments on draft documentation sent out for consultation from the health authority
- Contribute to creation of local labels as needed
- Coordinate submission schedule with Publishing ensuring delivery of high-quality documents
- Participate on cross-functional committees and sub-teamsin accordance withcompany initiatives as necessary
- Provides supervision and mentoring to junior regulatory professionals on the team if applicable
Requirements:
- BA/BS in a scientific field of study or BA/BS in another field of study and 8 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry including preferred experience with Gene Therapies and other compounds for the treatment of rare diseases
- Strong knowledge and experience in interpretation of EMEA regulations and guidelines related to drug development
- In depth understanding and application of industry standards and international regulations and guidelines.
- Experience in communicating regulatory strategy submission documents and plans both internally and externally
- The desire and ability to work in a fast-paced start-up environment
- Strong collaboration teamwork organizational skills at attention to detail
- Requires initiative creative problem-solving ability and excellent verbal and written communication skills
#LI-CK1 #LI-Hybrid
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 .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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:.
Required Experience:
Director
Why Join UsBe a hero for our rare disease patientsAt 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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means goi...
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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont 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 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.
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
Ultragenyx is seeking an experienced and highly motivatedAssociateDirector Regulatory Affairs (Clinical/Nonclinical Strategy)EMEAwho is a teamplayer and enjoys a fast paced dynamic work environment. TheAssociateDirector will beresponsible for developing keyEMEAregulatory strategies and executing submissions while monitoring and assessingEMEAregulations including GeneTherapyguidance and regulation changes.This position will report to theSenior Director Regulatory Affairs EMEA.
Work Model:
Flex: This role will typically require onsite work 2 days each week depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Interfaces with EMEA regulatory agencies as appropriateonselect programs.
- Independently research options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership.
- RepresentEMEARegulatory in sub team meetings serving as the point of contact for the assigned productsin the EMEA region and interfacing with functional areas including Research Development and Clinical in strategic development for early and late-stage products.
- Provideregulatory guidancefor the EMEA regionand input throughout product development to theregulatory subteam.
- Lead cross functional teams in EMEA Regulatory Filings ( GMOs MAAs)
- Lead selects Regulatory vendor meetings in alignment with product programs and Regulatory-driven projects
- MaintainCTAs ensuring Agency compliance
- Review clinical documentation including protocols DSURs Investigator Brochures Investigator Packages and General Investigational Plans to ensure GCP and Agency compliance
- Lead teams in the development of briefing documents for EMEA Agency meetings
- Manage and direct contractors/vendors as needed on programs
- Keep current with EMEA Agency guidelines and regulations
- Prepare comments on draft documentation sent out for consultation from the health authority
- Contribute to creation of local labels as needed
- Coordinate submission schedule with Publishing ensuring delivery of high-quality documents
- Participate on cross-functional committees and sub-teamsin accordance withcompany initiatives as necessary
- Provides supervision and mentoring to junior regulatory professionals on the team if applicable
Requirements:
- BA/BS in a scientific field of study or BA/BS in another field of study and 8 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry including preferred experience with Gene Therapies and other compounds for the treatment of rare diseases
- Strong knowledge and experience in interpretation of EMEA regulations and guidelines related to drug development
- In depth understanding and application of industry standards and international regulations and guidelines.
- Experience in communicating regulatory strategy submission documents and plans both internally and externally
- The desire and ability to work in a fast-paced start-up environment
- Strong collaboration teamwork organizational skills at attention to detail
- Requires initiative creative problem-solving ability and excellent verbal and written communication skills
#LI-CK1 #LI-Hybrid
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 .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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:.
Required Experience:
Director
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Job Location:
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
