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 isseekingan experienced and highly motivated Director Regulatory AffairsBrazilwho is ateam playerand thrives in afast-paced dynamic work environment.The Director willbe responsible fordeveloping key regulatory strategies andleadthe execution ofsubmissionsin Brazilwhilemonitoringand assessingapplicableregulations including Gene Therapy guidance and regulation changes.The Director will work closely with regional and globalregulatory colleagues functional areas and project teams to support regulatory activities inBrazil as a key market intheLatin Americaregion. TheDirector Regulatory AffairsBrazilwill be basedin Sao PauloBrazilwith hybrid model requiring some office-days.The position will report to the Senior Director RegulatoryAffairsLATAM.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Beresponsible forallRegulatory Affairs strategies for the portfolio and pipeline in Brazil.
- Provides strategic and technical input on regulatory requirements to development teamsatregulatory sub teamsand toleadership.
- Lead assessments of Life Cycle Management changes to provide strategic guidance and expert support to global teams by applying technical knowledgeexperienceand creative solutions.
- Leads all planning preparation and execution of regulatory interactions with ANVISA and other agenciesin Brazilfor select programs.
- RepresentBrazilRegulatory in sub team meetings serving as the point of contact for the assigned products and interfacing with functional areas including Research Development and Clinical in strategic development for late-stage products.
- Oversees submission processes and leads major applicationsin Brazil().
- Leadregulatorypartnerships with key stakeholders to deliverinnovative strategiesfacilitatinginteractionswith localpartners/consultants.
- Manage preparation of responses to questionsto ANSIVA and/or any health authorities inBrazilas well as prepare comments on draft documentation sent out for consultation from the health authority.
- Develop and implement regulatory policies processes and SOP in Brazil in compliance with Ultragenyx SOPs.
- Createscoordinatesandmaintainssubmission schedules and timelines with regulatory operations and the cross functional team ensuringtimelydelivery of high-quality documents.
- Keep current withBrazil and relevantAgency guidelines and regulations.
- Act as Pharmacovigilance (PV) Deputy in the absence of the Brazilian Pharmacovigilance Responsible where all PV responsibilities will be delegated to the deputy through a documented handover process.
- Contribute to creation of local labels as needed.
- Beregulatorypartner and lead contributioninVeevaPromoMatsprocess as needed.
- Provides supervision and mentoring to junior regulatory professionals on the team if applicable.
- Participate in cross-functional committees and sub-teamsin accordance withcompany initiatives as necessary.
- Strategic participation intrade associationsmeetings suchas SINDUSFARMAisrequired.
Requirements:
- Pharmacy degree preferred or BA/BS degree in life sciences and10years of relevant experience working in Regulatory in thepharmaceutical/ biotech degree preferred.
- The candidate must have hands on experiencefor at least5years withregulatory filingsbiologics/biotechand specialized therapies inBrazilaswell as preferred experience with Gene Therapies and other compounds for the treatment of rare diseases.
- In depth understanding and application of industry standards and international/ANVISAregulations and guidelinesfor MAA/CTAs/LCM drug registration processes.
- Sound knowledge of global regulatory framework drug development and post approval requirements includingforeign regulations and WHO/ICH isrequired.
- Experience workingwith high effectivenessand building strong partnershipswithkey internal andexternalstakeholders.
- Experience in communicating regulatory strategysubmissiondocuments and plans both internally and externally.
- The desire and ability to work in a fast-paced start-up environmenteagerto learn/apply new skills.
- Requires initiativeable to work independentlycreative problem-solving ability hands-on willing to workand excellent verbal and written communication skillsinPortugueseand a plus. Please complete your application and submit your CV in English.
- Demonstrated ability to strategizeprioritize contribute todecision-makingand managewith project management skillsmultipletaskssimultaneously.
#LI-CT1 #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 isseekingan experienced and highly motivated Director Regulatory AffairsBrazilwho is ateam playerand thrives in afast-paced dynamic work environment.The Director willbe responsible fordeveloping key regulatory strategies andleadthe execution ofsubmissionsin Brazilwhilemonitoringand assessingapplicableregulations including Gene Therapy guidance and regulation changes.The Director will work closely with regional and globalregulatory colleagues functional areas and project teams to support regulatory activities inBrazil as a key market intheLatin Americaregion. TheDirector Regulatory AffairsBrazilwill be basedin Sao PauloBrazilwith hybrid model requiring some office-days.The position will report to the Senior Director RegulatoryAffairsLATAM.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Beresponsible forallRegulatory Affairs strategies for the portfolio and pipeline in Brazil.
- Provides strategic and technical input on regulatory requirements to development teamsatregulatory sub teamsand toleadership.
- Lead assessments of Life Cycle Management changes to provide strategic guidance and expert support to global teams by applying technical knowledgeexperienceand creative solutions.
- Leads all planning preparation and execution of regulatory interactions with ANVISA and other agenciesin Brazilfor select programs.
- RepresentBrazilRegulatory in sub team meetings serving as the point of contact for the assigned products and interfacing with functional areas including Research Development and Clinical in strategic development for late-stage products.
- Oversees submission processes and leads major applicationsin Brazil().
- Leadregulatorypartnerships with key stakeholders to deliverinnovative strategiesfacilitatinginteractionswith localpartners/consultants.
- Manage preparation of responses to questionsto ANSIVA and/or any health authorities inBrazilas well as prepare comments on draft documentation sent out for consultation from the health authority.
- Develop and implement regulatory policies processes and SOP in Brazil in compliance with Ultragenyx SOPs.
- Createscoordinatesandmaintainssubmission schedules and timelines with regulatory operations and the cross functional team ensuringtimelydelivery of high-quality documents.
- Keep current withBrazil and relevantAgency guidelines and regulations.
- Act as Pharmacovigilance (PV) Deputy in the absence of the Brazilian Pharmacovigilance Responsible where all PV responsibilities will be delegated to the deputy through a documented handover process.
- Contribute to creation of local labels as needed.
- Beregulatorypartner and lead contributioninVeevaPromoMatsprocess as needed.
- Provides supervision and mentoring to junior regulatory professionals on the team if applicable.
- Participate in cross-functional committees and sub-teamsin accordance withcompany initiatives as necessary.
- Strategic participation intrade associationsmeetings suchas SINDUSFARMAisrequired.
Requirements:
- Pharmacy degree preferred or BA/BS degree in life sciences and10years of relevant experience working in Regulatory in thepharmaceutical/ biotech degree preferred.
- The candidate must have hands on experiencefor at least5years withregulatory filingsbiologics/biotechand specialized therapies inBrazilaswell as preferred experience with Gene Therapies and other compounds for the treatment of rare diseases.
- In depth understanding and application of industry standards and international/ANVISAregulations and guidelinesfor MAA/CTAs/LCM drug registration processes.
- Sound knowledge of global regulatory framework drug development and post approval requirements includingforeign regulations and WHO/ICH isrequired.
- Experience workingwith high effectivenessand building strong partnershipswithkey internal andexternalstakeholders.
- Experience in communicating regulatory strategysubmissiondocuments and plans both internally and externally.
- The desire and ability to work in a fast-paced start-up environmenteagerto learn/apply new skills.
- Requires initiativeable to work independentlycreative problem-solving ability hands-on willing to workand excellent verbal and written communication skillsinPortugueseand a plus. Please complete your application and submit your CV in English.
- Demonstrated ability to strategizeprioritize contribute todecision-makingand managewith project management skillsmultipletaskssimultaneously.
#LI-CT1 #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
View more
View less
Job Location:
Monthly Salary:
Posted on:
21 hours ago
Vacancies:
1 Vacancy
