Position Summary:

Work Model:

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 application forms, cover letters, coordinating translations, creation of content plan and archival in Veeva RIM of final submissions and correspondence, etc.
• Assist in drafting meeting minutes, request quotations, request/follow up to contract process, develop and keep trackers and regulatory databases.
• Assist with requesting Health Authority meetings, as necessary to support regulatory filings and applications.
• 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.
• Must be highly motivated, curious, and eager to learn/apply new skills.
• 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