Senior Associate, Regulatory Strategy – Infectious Diseases, Biological Products

This is a fully remote position, open to applicants in Mexico, +3 more countries.

📋 Description

• Assist the Director of Regulatory Affairs & Quality Assurance in implementing regulatory strategies and priorities pertaining to the product lifecycle.

• Conduct initial assessments of regulatory impacts for suggested global changes and advise on submission requirements, sequencing, dependencies, documentation necessities, and timelines.

• Recognize and evaluate regulatory risks, issues, dependencies, and potential delays; escalate these concerns along with proposed mitigation strategies.

• Track regulatory requirements, COFEPRIS criteria, procedural updates, and evolving practices; provide regulatory intelligence and impact evaluations.

• Aid in regulatory procedures concerning COFEPRIS, including the preparation and follow-up of submissions, responses to inquiries, commitments, and post-approval activities.

• Oversee the regulatory activities related to labeling and artwork, including local prescribing information, packaging components, approved conditions, and updates related to safety.

• Maintain a comprehensive regulatory portfolio that encompasses registrations, submissions, approvals, commitments, renewals, post-approval changes, authority requests, dependencies, and milestones.

• Keep regulatory plans, submission timelines, trackers, and status reports up to date; provide operational progress updates.

• Manage assigned regulatory activities from start to finish, overseeing inputs, timelines, document readiness, follow-ups, and closure.

• Coordinate regulatory assessments and the implementation of CMC and manufacturing-related changes.

• Collaborate with Global Regulatory CMC, Quality, and Supply Chain teams.

• Maintain regulatory records, submissions, approvals, correspondence, and commitments in relevant systems and repositories.

• Assist with local Quality activities, compliance requirements, quality events, and readiness for inspections and audits.

• Work alongside Global Regulatory, Regional Regulatory, Medical, Pharmacovigilance, Supply Chain, Quality, Commercial, and other cross-functional teams.

• Elevate strategic decisions, significant risks, and sensitive matters to the Director.

⛳️ Requirements

• BA/BS degree in a scientific, engineering, or healthcare field.

• Over 5 years of experience in the pharmaceutical industry, ideally in LATAM countries.

• More than 3 years of experience in regulatory strategy or relevant training/experience.

• Outstanding written and verbal communication skills in both English and Spanish.

• Strong understanding of current US and EU regulations.

• Extensive experience with the CTD format and content of regulatory filings.

• Knowledge and comprehensive experience with regulatory procedures and legislation related to drug development, product registration, line extensions, and license maintenance.

• Proven strong organizational abilities, including the capability to prioritize workload effectively.

• Experience in preparing regulatory submissions and supportive amendments or supplements.

• Experience in authoring regulatory documents.

• Familiarity with and comprehension of applicable regulations.

• Preferred: Master's, PharmD, or PhD degree.

• Preferred: Experience in Infectious Diseases and Biologicals.

• Preferred: Experience with products under development, particularly concerning clinical and pre-clinical regulatory aspects.

• Preferred: Familiarity with regulatory procedures and legislation from both US and EU markets.

🏝️ Benefits

• No specific benefits, perks, or compensation extras stated.