Regulatory Affairs Specialist – Start-up
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Job Description
Regulatory Affairs Specialist at Synvia improving lives through innovative pharmaceutical solutions. Handling regulatory submissions and analyzing drug master files while ensuring compliance with Brazilian regulations.
Responsibilities:
- Handle sponsors’ requests with the required level of detail and grounding in current legislation;
- Participate in discussions to define the best strategy for different projects (clinical research and products);
- Assist in the feasibility assessment of various projects;
- Identify potential risks and opportunities for projects arising from changes in legislation and/or applicable requirements;
- Perform critical review of technical dossiers for purposes of registration and post-registration of medicines in Brazil;
- Prepare and review documents, including compiling clinical research dossiers for different categories of medicinal products for submission to Anvisa;
- Conduct due diligence of regulatory documentation;
- Prepare regulatory opinions and scientific regulatory reports;
- Assist in the design and discussion of the clinical development plan for an investigational product;
- Prepare technical responses to requirements issued by the competent authorities;
- Monitor publications of interest to the company and/or sponsors in the Official Gazette of the Union (Diário Oficial da União);
- Stay up to date with regulations and technical requirements applicable to the Brazilian regulatory agency and international guidelines for planning, conducting and submitting projects;
- Participate in specific technical working groups of external organizations when the topic has a significant impact on the company and/or sponsors.
Requirements:
- Bachelor’s degree in Pharmacy-Biochemistry, Biomedicine, Biology, Biotechnology or related fields;
- Regulatory writing skills;
- Ability to assess Drug Master Files (DMFs);
- Experience analyzing and reviewing regulatory dossiers;
- Knowledge of analytical validation, with the ability to review and interpret technical reports;
- Knowledge of healthcare/sanitary legislation;
- Advanced English;
- Intermediate Spanish;
- Advanced Microsoft Office skills;
- Training in Good Clinical Practice (GCP).
- Differentials:
- Experience with biological/biologic medicines;
- Experience with regulatory processes related to clinical studies or regulatory start-up.
Benefits:
- Commuting allowance (Vale Transporte);
- Parking (subject to availability);
- Health plan with no monthly fee for the employee; copay for tests and consultations applies;
- Dental plan with employee copayment;
- Life insurance at no cost to the employee;
- Flexible meal/food allowance;
- Pharmacy discount program;
- Vaccination program;
- Synvia Partnerships Club (education, language schools, leisure and culture);
- Flexible time bank – holidays and commemorative dates (per internal policy);
- SESC partnership;
- Physical wellness program – TotalPass;
- Day Off – Health Professional;
- Childcare assistance (per internal policy).
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