Analista de Assuntos Regulatórios Sênior – DMF
New
J
JobgetherPharmaceutical Regulatory Affairs
BrazilFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Advanced English proficiency
- Required Skills
- Project ManagementStakeholder management
Requirements
- 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.
Responsibilities
- 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.
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