Contractor - Manager, Regulatory Affairs Latam

**Why Join Us?**
- Be a hero for our rare disease patients_

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**:
Ultragenyx is seeking an experienced and highly motivated Contractor/consultant-Manager, Regulatory Affairs LATAM who is a team player and thrives in a fast-paced, dynamic work environment. The 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 knowledge of global rules, regulations, and guidance's governing the commercialization and development of drugs and biologics in all phases. The Manager, Regulatory Affairs, LATAM will be based Bogota, Colombia with hybrid model requiring 3 days-office. The position will be hired with a contract through Michael Page-Colombia.

**_ ultra_**_innovative - Tackle rare and dynamic challenges_

**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**:

- Independently researches options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership
- Manage preparation of responses to questions from health authorities in the LATAM markets
- Interface and develop partnerships with key stakeholders to deliver strategies, facilitating interactions with local partners/consultants
- Creates and maintains submission schedules and timelines with regulatory operations and the cross functional team, ensuring timely delivery of high-quality documents
- Support the LATAM regulatory team in all activities related to setting up SOPs, procedures, and databases for the department
- Participate in cross-functional committees and sub-teams in accordance with company initiatives, as necessary
- Strategic participation in trade-associations meetings as required
- Support (non-)promotional material revision and approval for the LATAM markets in the system established for such activity

**Requirements**:

- Pharmacy degree preferred or BA/BS degree in life sciences
- Relevant scientific background with 4-6 years of experience in Regulatory Affairs associated roles in the biotech or pharmaceutical industries with at least two-years of experience in Regulatory Affairs in the LATAM region
- Relevant knowledge and experience in interpretation of LatAm regulations for MAA/LCM drug registration processes. Knowledge of foreign regulations and ICH is required
- Knowledge of orphan drug/biologics products is a plus
- Experience working with external regulatory consultants is a plus
- 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
- Demonstrated ability to strategize, prioritize and manage with project management skills multiple tasks simultaneously

**#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_
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