Senior Regulatory Consultant – LATAM, Biologics, CTA

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

📋 Description

• Assist in the implementation of global regulatory CMC for marketed products across multiple product lines.

• Aid in the preparation and submission of regulatory CMC documentation.

• Provide regulatory assistance to various cross-functional teams.

• Execute the commercial Lifecycle Management strategy and submissions, with a focus on the US, Canada, and EU.

• Review CMC sections of regulatory submissions and manage interactions and responses with regulatory agencies.

• Collaborate with regulatory colleagues to formulate global regulatory CMC strategies and submissions.

• Actively participate in cross-functional teams.

• Serve as the main regulatory CMC contact for designated products and projects when applicable.

⛳️ Requirements

• A Bachelor's degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or a related life-science discipline.

• Generally requires 4 years of experience in the pharmaceutical sector or a related field, or an equivalent combination of education and experience.

• Expertise in regulatory guidelines from the FDA, EMA, Health Canada, and ICH.

• Excellent interpersonal skills for exchanging complex information and guiding others.

• Strong problem-solving abilities.

• Capability to collaborate and communicate in an open, clear, complete, timely, and consistent manner.

• Strong planning and prioritization skills, with the ability to work effectively with all levels of management.

• Comprehensive knowledge of cGMP, FDA, EMA, and ICH standards.

• Experience with biologics and CTA is required for this position.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• An inclusive work culture.

• Reasonable accommodations provided when appropriate under the Americans with Disabilities Act.