Regulatory Strategist – International, Manager

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

📋 Description

• Lead and support submissions within the Latin American markets for Marketing Authorization Applications (MAAs) and life-cycle management procedures.

• Provide local expertise as part of the Global Regulatory Affairs team and assist in establishing and implementing best practices.

• Drive and coordinate regulatory strategy along with local regulatory activities across Latin America.

• Offer regional regulatory expertise to facilitate geographical expansion.

• Monitor requests from Health Authorities and relevant new local regulations, and relay them to the appropriate GRA contact.

• Stay updated on local requirements and communicate any regulatory changes to Regulatory Senior Management.

• Lead cross-functional teams in preparing submission activities from the planning stage through to submission and review, including addressing inquiries.

• Assist submission leads by creating timelines, developing submission binders, and maintaining submission and correspondence files.

• Serve as the local expert for regulatory inquiries from other functions, such as medical and supply chain, regarding regulatory requirements, local labelling guidance, Common Technical Document (CTD), and Good Manufacturing Practices (GMPs).

• Ensure compliance of all work with regulatory requirements and company policies and procedures.

⛳️ Requirements

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

• Awareness of current trends in local and regional regulatory requirements.

• Recognized as a knowledgeable resource for regulatory advice by other departments.

• Experience in interacting with Regulatory Authorities.

• Ability to facilitate interactions with International Regulatory Affairs, various internal departments, and external partners, primarily submission partners.

• Bachelor's degree in Pharmaceutical Sciences.

• Proficient in written and spoken English.

• Knowledge of Spanish and Portuguese is considered an advantage.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Total rewards program.

• Inclusive culture.

• Reasonable accommodations when appropriate.