Regulatory Affairs Analyst

MSN Laboratories; São Paulo; Presencial; BRL 120 000 - 200 000; Tempo integral

Resumo da oferta

MSN Laboratories is seeking an Regulatory Affairs Analyst to manage regulatory submissions and ensure compliance with local and international regulatory requirements in the pharmaceutical sector. The role supports new product registrations, post-marketing activities, and execution of regulatory strategy.

The candidate will prepare CTD dossiers, respond to ANVISA deficiency letters, perform risk assessments, and coordinate biowaivers and regulatory strategies to ensure timely approvals and robust

Qualificações

• Minimum 5 years of experience in Regulatory Affairs or Technical Documentation within the pharmaceutical industry.
• Strong working knowledge of ANVISA regulations and international regulatory guidelines.
• Experience in formulations (finished dosages) is mandatory.

Responsabilidades

• Prepare, review, and submit CTD dossiers for new drug product registrations and post‑marketing variations in compliance with regulatory requirements.
• Prepare and respond to Deficiency Letters issued by ANVISA, ensuring timely and accurate submissions.
• Conduct risk assessments and gap analyses to enhance regulatory processes and improve dossier quality.
• Develop and implement regulatory strategies for Pharmaceutical Equivalence Studies and Biowaivers, including coordination of outsourcing activities.
• Support and monitor the importation process in line with regulatory compliance requirements.
• Evaluate regulatory feasibility and identify potential risks or requirements to support project execution.

Formação académica

Bachelor’s degree or higher in Pharmacy, Chemistry, Biology, Biomedicine, or a related field

Descrição da oferta de emprego

The Regulatory Affairs Analyst will be responsible for managing regulatory submissions and ensuring compliance with local and international regulatory requirements. This role plays a key part in supporting new product registrations, post-marketing activities, and regulatory strategy execution within the pharmaceutical domain.

• Prepare, review, and submit high-quality CTD dossiers for new drug product registrations and post-marketing variations in compliance with regulatory requirements.
• Prepare and respond to Deficiency Letters issued by ANVISA, ensuring timely and accurate submissions.
• Conduct risk assessments and gap analyses to enhance regulatory processes and improve dossier quality.
• Develop and implement regulatory strategies for Pharmaceutical Equivalence Studies and Biowaivers, including coordination of outsourcing activities.
• Support and monitor the importation process in line with regulatory compliance requirements.
• Evaluate regulatory feasibility and identify potential risks or requirements to support project execution.

Qualifications & Experience

• Minimum 5 years of experience in Regulatory Affairs or Technical Documentation within the pharmaceutical industry.
• Bachelor’s degree or higher in Pharmacy, Chemistry, Biology, Biomedicine, or a related field.
• Strong working knowledge of ANVISA regulations, as well as international regulatory guidelines and processes.
• Proven ability to manage regulatory documentation with accuracy, attention to detail, and compliance focus.
• Experience in formulations (finished dosgages) is mandatory/compuslory