Mid-level Regulatory Affairs Analyst – New Registrations

Role Overview

• Ensure compliance with current regulations in registration dossiers through the preparation and review of regulatory-technical documents, assessing associated risks and proposing mitigation strategies.
• Participate from product development and registration stages through to product launch, supporting the team and cross-functional areas.
• Ensure compliance with current regulations in commercial/licensing partner dossiers by performing regulatory-focused due diligence, assessing risks and defining mitigation strategies.
• Contribute to responding to regulatory queries by analyzing questions and developing regulatory-technical strategies to meet ANVISA expectations together with external partners (in the case of a licensee) and/or internal partners (for in-house development projects).
• Assist in regulatory-technical meetings with ANVISA or other regulatory authorities, when necessary, by preparing strategy and materials together with internal stakeholders.
• Contribute to the investigation of quality deviations and the development of strategies and action plans that ensure compliance with current regulations, with a regulatory-technical focus.
• Contribute to regulatory-technical discussions with industry associations and/or ANVISA by proposing initiatives that can shape the regulatory environment.
• Provide regulatory support to internal clients by supplying information on products under your responsibility, clarifying ANVISA regulations and supporting technical discussions to assess regulatory impact.
• Contribute to project governance by keeping information updated in the core team’s control and tracking tools.
• Prepare dossiers and submit registration applications in accordance with applicable regulations.

Requirements

• Bachelor's degree required in Pharmacy, Biochemistry, Chemistry, Biology or Biomedicine.
• Intermediate English.
• Proficiency in Microsoft Office.
• Knowledge and/or experience with international guidelines and regulations (ICH, EMA, FDA).
• Experience with registration of synthetic (small-molecule) medicines in Brazil is required.
• Experience preparing and submitting CTD (Common Technical Document) registration dossiers is required.
• Experience performing regulatory technical review of CMC/quality documentation for registration, assessing risks and proposing mitigation strategies is required.
• Experience responding to regulatory queries/deficiencies by analyzing questions and developing technical and regulatory strategies together with internal and external development teams is required.
• Experience working with international partners, ensuring compliance in licensing dossiers through regulatory-focused due diligence, assessing risks and defining mitigation strategies is required.
• Knowledge of analytical method development and validation, drug stability, bioequivalence studies and dissolution profiles, ANVISA regulations related to drug quality (for example: RDC 53/15, RDC 964/25, RDC 31/10, RDC 318/19, RDC 166/17), pharmaceutical processes and drug development is required.
• Desirable: knowledge of Project Management and Agile methodologies.
• Preferred courses: postgraduate studies in Regulatory Affairs, Analytical Development, Pharmaceutical/Formulation Development and Technical Documentation.
• Desirable: experience with biological products (higher complexity), monoclonal antibodies and vaccines.
• Knowledge of other product categories (e.g., food, medical devices) will be considered a differential.

Benefits

• Meal voucher.
• Grocery allowance.
• Libbs medicines – 100% coverage.
• Pharmacy agreement – Vidalink.
• PPR
• Company Profit and Results Sharing Program.
• Parking, commuting allowance or company shuttle (applicable only for shift work).
• USE Program: subsidy for purchasing equipment to be used for work, which may also be used for personal purposes.
• Flexible benefits (TotalPass, life insurance, private pension, health care, dental care and meal allowance).