Contract Regulatory Affairs Associate Ii

4 meses atrás

São Paulo SP, Brasil Ultragenyx Pharmaceutical Tempo inteiro

**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**:
**_ ultra_**_impact - Make a difference for those who need it most_

The Associate II, Regulatory Affairs LATAM will be responsible for providing support for all regulatory aspects for MAA and LCM for marketed and new products; and CTA for pipeline products. The responsibilities include support for preparation of a variety of regulatory submissions and working closely with functional areas and project teams. In addition, support to administrative and project management activities as well as keep the regulatory systems up to date. The individual must possess basic knowledge of rules, regulations, and guidances governing synthetic products (small molecules) and biological products in all phases of development. Any level of experience with Gene Therapies is a plus. Excellent verbal and written communication skills in Portuguese and English are required. Spanish is a plus. The Associate II, Regulatory Affairs LATAM will be based São Paulo, Brazil.

**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**:

- Assist with the development of basic regulatory documents to ensure we meet the health authority requirements for submissions of high quality.
- Assist with creating and maintaining regulatory timelines and tracking deliverables to ensure regulatory submission timelines are met.
- Assist in drafting meeting minutes, request quotations, request/follow up to contract process, develop and keep trackers and regulatory databases.
- Support the local regulatory team in all activities related to setting up SOPs, procedures, and databases for the department.
- Support timely update of the regulatory affairs filings tracking system for LATAM correspondence with the authorities.
- Maintain knowledge of current regulations and guidances governing synthetic products (small molecules), biological products and gene therapies in all phases of development, as well as knowledge of therapeutic area.

**Requirements**:

- Bachelor's degree in Pharmacy.
- Experience in Regulatory Affairs in the pharmaceutical industry is desirable.
- Outstanding verbal, written and interpersonal communication skills in Portuguese and English. Knowledge of Spanish is a plus.
- Motivated, self-starter, and able to work independently with supervision and in a team environment.
- Demonstrated ability to prioritize multiple tasks simultaneously.
- Demonstrated understanding of ANVISA's synthetic products (small molecules) and biological products registration regulations and guidelines; Knowledge of foreign regulations and ICH is a plus.
- Knowledge of orphan drug development is a plus.
- Knowledge of gene therapies requirements is a plus.
- Knowledge of Clinical Trial Applications (DDCM and DDCTA) is a plus.
- Interest in working in a growing biotech company, partnering with the members of regulatory team and regional/global teams to overcome the challenges and develop solutions.
- PC literacy required; proficient use of technology including MS Office skills (Outlook, Word, Excel, Powerpoint and Internet resources is expected).
- EDMS and Power BI skills are a plus. **#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_
- See our _CCPA Employee and Applicant Privacy Notice_._
- See our _Privacy Policy_._

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