Analista de Assuntos Regulatórios Sênior – DMF

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Analista de Assuntos Regulatórios Sênior – DMF based in Brazil.

This role offers the opportunity to contribute to the regulatory strategy and lifecycle management of innovative pharmaceutical products. You will act as a technical reference in Drug Master File (DMF/DIFA) processes, ensuring regulatory compliance and operational excellence. The position combines technical expertise, strategic thinking, and collaboration with multidisciplinary teams and external partners. You will support critical decisions involving active pharmaceutical ingredients (APIs), from supplier qualification to post-registration activities. Working in a dynamic healthcare environment, you will help ensure the quality, safety, and sustainability of a diverse pharmaceutical portfolio. This is an ideal opportunity for professionals passionate about regulatory affairs, innovation, and improving access to high-quality healthcare solutions.

Accountabilities:: The Senior Regulatory Affairs Analyst will be responsible for managing complex regulatory activities related to active pharmaceutical ingredients, supporting product development, registration, and lifecycle management while ensuring alignment with regulatory requirements and business objectives.

Act as a technical expert in DIFA and CADIFA processes, providing strategic guidance, regulatory insights, and risk management support.

Manage regulatory activities throughout the API lifecycle, from manufacturer qualification and selection to registration and post-registration changes.

Support internal teams such as supplier qualification, analytical development, pharmaceutical development, and procurement during API evaluation and approval processes.

Develop regulatory strategies based on national and international guidelines related to DMF/DIFA requirements.

Perform critical technical and regulatory assessments of API documentation, partnership dossiers, synthesis routes, and impurity profiles.

Support the evaluation and management of technical and regulatory risks impacting product development, registration, and maintenance.

Coordinate projects, define priorities, monitor timelines, and manage deadlines with internal stakeholders and national/international suppliers.

Negotiate technical responses, additional documentation requests, and timelines with API manufacturers.

Provide technical support during discussions with internal teams, suppliers, and regulatory stakeholders.

Monitor new regulatory requirements, evaluate their impact, and promote multidisciplinary discussions to ensure compliance.

Drive continuous improvement initiatives, share knowledge, mentor colleagues, and contribute to the development of regulatory capabilities.

Requirements:

The ideal candidate has strong experience in pharmaceutical regulatory affairs, particularly in API documentation and lifecycle management, with the ability to navigate complex regulatory environments and collaborate with multiple stakeholders.

Bachelor’s degree in a scientific field such as Pharmacy, Biochemistry, Chemistry, or related areas.

Advanced English proficiency, including reading, writing, and communication skills.

Extensive experience with national and international regulations and guidelines related to active pharmaceutical ingredients.

Proven experience analyzing complete DIFA/DMF documentation and evaluating API manufacturer qualification processes.

Experience assessing synthesis routes for synthetic and semi-synthetic APIs and impurity profiles.

Experience negotiating technical document requests and timelines with national and international API manufacturers.

Knowledge of API lifecycle management, including evaluation of manufacturer changes and post-registration regulatory strategies.

Ability to interpret regulations, identify risks, and develop effective regulatory approaches.

Strong project management skills, including prioritization, planning, and deadline management.

Excellent communication, negotiation, and stakeholder management skills.

Nice-to-have qualifications:

Additional training in Regulatory Affairs, Project Management, Process Management, or Risk Management.

Experience with chemical synthesis in pharmaceutical industry or academic environments.

Postgraduate studies in General Chemistry, Organic Chemistry, or related fields.

Benefits:

Fully remote work model based in Brazil.

Flexible working hours, Monday to Friday, with adaptable start and end times.

Meal allowance.

Food allowance.

100% coverage for company medicines.

Pharmacy partnership benefits.

Profit-sharing program.

Transportation support options, including parking, transportation allowance, or company shuttle where applicable.

Equipment support program for purchasing work devices, with personal use flexibility.

Flexible benefits package including:

Fitness and wellness partnerships.

Life insurance.

Private pension plan.

Medical insurance.

Dental insurance.

Additional food allowance support.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1