Regulatory Strategist

This is a fully remote position, open to applicants in Canada.

📋 Description

• Lead and facilitate submissions within Latin American markets for Marketing Authorization Applications (MAAs) and lifecycle management processes.

• Offer local regulatory insights as part of the Global Regulatory Affairs team.

• Develop and coordinate regulatory strategies and local regulatory activities across Latin America.

• Provide regional regulatory guidance for geographical expansion initiatives.

• Monitor Health Authority inquiries and pertinent new local regulations.

• Stay informed about local requirements and relay regulatory updates to senior management.

• Guide cross-functional teams through the processes of submission planning, preparation, submission, and review.

• Draft responses to regulatory inquiries.

• Create timelines and assemble submission binders using Veeva.

• Ensure submission and correspondence files are current and well-maintained.

• Act as the local authority for regulatory inquiries from medical, supply chain, and other operational functions.

• Guarantee compliance with regulatory standards as well as company policies and procedures.

⛳️ Requirements

• Relevant experience in regulatory affairs within the Latin American industry.

• Comprehension of current trends in local and regional regulatory standards.

• Be a knowledgeable resource for regulatory guidance.

• Experience engaging with Regulatory Authorities.

• Ability to facilitate communications with International Regulatory Affairs, internal teams, and external submission partners.

• Bachelor’s degree in Pharmaceutical Sciences.

• Proficient in written and spoken English.

• Knowledge of Spanish and Portuguese is considered a plus.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations available when appropriate.