Senior Manager Regulatory Affairs LATAM, Bogota Colombia

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Ultragenyx is seeking an experienced and highly motivated SR Manager, Regulatory Affairs LATAM who is a team player and thrives in a fast-paced, dynamic work environment. The Sr Manager will work closely with regional and global regulatory colleagues, functional areas, and project teams to support regulatory activities in the Latin America region. The individual must possess relevant knowledge of global rules, regulations, and guidance’s governing the commercialization and development of drugs and biologics in all phases. The SR Manager, Regulatory Affairs, LATAM will be based City of Bogota, Colombia with hybrid model requiring some office-days. 

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. Prepare and manage filings of regulatory marketing authorization (MA) applications in the LATAM territories, as required by the regulatory plan. 
2. Person will be Product Head for one/more products part of Ultragenyx portfolio with LATAM regulatory scope. 
3. Lead assessments of Life Cycle Management changes to provide guidance and support to global teams by applying technical knowledge, experience and strategic solutions. 
4. Independently research options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership. 
5. Manage preparation of responses to questions from health authorities in the LATAM markets. 
6. Lead partnerships with key stakeholders to deliver innovative strategies, facilitating interactions with local partners/consultants. 
7. Creates and maintains submission schedules and timelines with regulatory operations and the cross functional team, ensuring timely delivery of high-quality documents. 
8. Participate in cross-functional committees and sub-teams in accordance with company initiatives, as necessary. 
9. Strategic participation in trade-associations meetings is required. 
10. Support the preparation of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages and slide deck presentations. 

Requirements:

1. Pharmacy degree preferred or BA/BS degree in life sciences.  
2. Relevant scientific background with 6-8 years of experience in Regulatory Affairs associated roles in the biotech or pharmaceutical industries with at least three years of experience in Regulatory Affairs in the LATAM region.  
3. The candidate must have hands on experience with regulatory filings in at least one of the following markets: Mexico, Colombia, Argentina, Central America, or Brazil.  
4. Strong knowledge and experience in interpretation of LatAm regulations for MAA/LCM drug registration processes. Knowledge of foreign regulations and ICH is required.  
5. Knowledge of orphan drug/biologics products is a plus. 
6. Experience working with external regulatory consultants is a plus. 
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 with supervision, creative problem-solving ability, hands-on willing to work, and excellent verbal and written communication skills in Spanish and English. Portuguese is a plus. 
9. Demonstrated ability to strategize, prioritize and manage with project management skills multiple tasks simultaneously. 

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