Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Ensuring compliance with regulations in clinical and pharmaceutical processes at Eurofarma. Leading documentation efforts and liaising with international partners for product submissions.
Responsibilities
- Serve as the focal point for due diligence processes of product dossiers from international partnerships (especially innovative products), evaluating documentation, defining the action plan and tracking it through to dossier submission in the target countries. Lead the project as the primary interlocutor in meetings with partners, internal technical teams and the new business area.
- Carefully assess technical documentation across clinical, pharmacokinetic, manufacturing, pharmaceutics and analytical scopes, identifying and classifying risks and impacts and proposing action plans to resolve or mitigate gaps.
- Prepare core registration dossiers in CTD format to meet the requirements of Brazil and Eurofarma subsidiaries, always mindful of deadlines.
- Lead the development of strategies to respond to regulatory requests and monitor timelines.
- Monitor the creation and evolution of global project schedules, ensuring that development proceeds as planned during technical feasibility assessments and that regulatory and clinical strategies are included in the project timeline. Provide critical oversight of project progress to help prevent major post‑registration delays for product launches in Brazil and LATAM.
- Contribute to updating and disseminating tools for national and international regulatory requirements. Participate in the investigation of requirements for new markets. Stay up to date on changes in health regulations, reflect updates across pipeline projects and ensure that any adjustments required by regulatory updates are implemented.
Requirements
- Bachelor's degree in Pharmaceutical Biochemistry and/or Industrial Pharmacy
- Postgraduate degree preferred in areas related to drug development, regulatory affairs, project management or clinical research
- Experience in regulatory affairs, R&D, or clinical research
- Knowledge of ANVISA and international regulations such as ICH required; experience with LATAM, EMA and FDA regulations is a plus. Knowledge in pharmaceutical technology, analytical methods, pharmaceutics, bioequivalence and clinical study design
- Proficiency with Office 365/SharePoint — sites, lists, Planner, Power BI
- Experience with the Veeva system
- Fluent in English; intermediate Spanish
Benefits
- Health insurance
- Dental insurance
- Meal allowance
- On-site cafeteria
- Transportation allowance/shuttle/parking — depending on work location
- On-site pharmacy/dispensary with free medications for you, your parents, spouse and children
- Life insurance
- Private pension plan to help you plan your future
- Childcare assistance (depending on work location)
- On-site beauty salon
- On-site gym
- Short Friday (early finish) to make the most of your day — 6-hour workday for employees who do not work shifts
- Development programs with partnerships at educational institutions offering discounts
- Maternity leave
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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