Regulatory Affairs Analyst – Sr
Cellera Farma
full-time
Posted on:
Location Type: Hybrid
Location: Indaiatuba • Brasil
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Job Level
About the role
- Responsible for preparing regulatory dossiers to obtain approvals for new products and to maintain portfolio products
- Preparation of product registration and post-registration dossiers for submission to ANVISA
- Experience with CTD-format dossiers
- Review and approval of marketing/promotional materials
- Review and approval of package inserts and labeling
- Provide support to internal departments (marketing, manufacturing, R&D, etc.)
- Monitor and interpret regulatory changes to anticipate impacts on the company’s business
- Strategic market perspective with a focus on Regulatory Intelligence
Requirements
- Bachelor’s degree in Pharmacy
- Postgraduate education preferred
- Intermediate English
- Proven experience in the role interacting with regulatory authorities: ANVISA, VISA and other regulatory bodies, serving as a technical reference in the area
- Strong command of legislation and standards: up-to-date, in-depth knowledge of sanitary legislation (RDCs, local and international standards)
- Experience with product registrations and post-registration activities
- Intermediate Microsoft Office skills
- Strong verbal and written communication skills
- Proactivity
- Team player
- Good interpersonal skills
- Results-oriented
- Autonomy
- Ability to anticipate risks and provide strategic support for decision-making
- Client commitment
- Ability to apply and share knowledge
- Change agent mentality
- Discipline
- Patience
- Organizational skills
- Analytical and detail-oriented mindset
Benefits
- Monthly meal allowance
- Medical and dental plans
- Profit-sharing (PLR)
- Home office policy (4x1)
- Medication reimbursement policy
- Childcare assistance
- Life insurance
- Year-end/Christmas allowance
- Partnerships offering course discounts
- Shuttle service (Campinas - Indaiatuba)
- Wellhub (comprehensive health and wellness platform)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory dossiers preparationCTD-format dossiersproduct registrationpost-registration activitiessanitary legislationRDCsregulatory intelligencemarketing materials reviewpackage inserts reviewlabeling approval
Soft Skills
strong verbal communicationstrong written communicationproactivityteam playerinterpersonal skillsresults-orientedautonomyrisk anticipationstrategic supportorganizational skills
Certifications
Bachelor’s degree in PharmacyPostgraduate education