Director, Regulatory Affairs Brazil

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Ultragenyx is seeking an experienced and highly motivated Director, Regulatory Affairs Brazil who is a team player and thrives in a fast-paced, dynamic work environment. The Director will be responsible for developing key regulatory strategies and lead the execution of submissions in Brazil while monitoring and assessing applicable regulations including Gene Therapy guidance and regulation changes. The Director will work closely with regional and global regulatory colleagues, functional areas, and project teams to support regulatory activities in Brazil as a key market in the Latin America region. The Director, Regulatory Affairs Brazil will be based in Sao Paulo, Brazil with hybrid model requiring some office-days. The position will report to the Senior Director, Regulatory Affairs LATAM. 

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. Be responsible for all Regulatory Affairs strategies for the portfolio and pipeline in Brazil. 
2. Provides strategic and technical input on regulatory requirements to development teams, at regulatory sub teams and to leadership. 
3. Lead assessments of Life Cycle Management changes to provide strategic guidance and expert support to global teams by applying technical knowledge, experience and creative solutions. 
4. Leads all planning, preparation, and execution of regulatory interactions with ANVISA and other agencies in Brazil for select programs. 
5. Represent Brazil Regulatory 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. 
6. Oversees submission processes and leads major applications in Brazil (e.g. MAAs, CTAs, LCM, GMPc). 
7. Lead regulatory partnerships with key stakeholders to deliver innovative strategies, facilitating interactions with local partners/consultants. 
8. Manage preparation of responses to questions to ANSIVA and/or any health authorities in Brazil as well as prepare comments on draft documentation sent out for consultation from the health authority. 
9. Develop and implement regulatory policies, processes, and SOP in Brazil in compliance with Ultragenyx SOPs. 
10. Creates, coordinates and maintains submission schedules and timelines with regulatory operations and the cross functional team, ensuring timely delivery of high-quality documents. 
11. Keep current with Brazil and relevant Agency guidelines and regulations. 
12. 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. 
13. Contribute to creation of local labels as needed. 
14. Be regulatory partner and lead contribution in Veeva PromoMats process as needed. 
15. Provides supervision and mentoring to junior regulatory professionals on the team, if applicable. 
16. Participate in cross-functional committees and sub-teams in accordance with company initiatives, as necessary. 
17. Strategic participation in trade associations meetings such as SINDUSFARMA is required. 

Requirements:

1. Pharmacy degree preferred or BA/BS degree in life sciences and 10 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry. Advanced degree preferred​. 
2. The candidate must have hands on experience for at least 5 years with regulatory filings biologics/biotech and specialized therapies in Brazil, as well as preferred experience with Gene Therapies and other compounds for the treatment of rare diseases. 
3. In depth understanding and application of industry standards and international/ ANVISA regulations and guidelines for MAA/CTAs/LCM drug registration processes.  
4. Sound knowledge of global regulatory framework, drug development and post approval requirements including foreign regulations and WHO/ICH is required.  
5. Experience working with high effectiveness and building strong partnerships with key internal and external stakeholders. 
6. Experience in communicating regulatory strategy, submission documents and plans both internally and externally. 
7. The desire and ability to work in a fast-paced, start-up environment, eager to learn/apply new skills. 
8. Requires initiative, able to work independently, creative problem-solving ability, hands-on willing to work, and excellent verbal and written communication skills in Portuguese and English. Spanish is a plus. Please complete your application and submit your CV in English. 
9. Demonstrated ability to strategize, prioritize, contribute to decision-making and manage with project management skills multiple tasks simultaneously.

#LI-CT1 #LI-Hybrid