Aché Laboratórios is a Brazilian pharmaceutical manufacturer with nearly six decades of experience developing, producing, and commercializing prescription and over-the-counter medicines. Its portfolio also includes generics, dermocosmetics, and nutraceutical supplements, serving both healthcare professionals and consumers. The company combines pharmaceutical research and product development with large-scale manufacturing, commercial partnerships across Brazil, pharmacovigilance, regulatory compliance, and sustainability initiatives, including ISO certifications and carbon-neutral efforts.
Regulatory Affairs Coordinator
Lead regulatory affairs at Aché, a Brazilian pharmaceutical company, guiding a team and shaping regulatory strategies. Oversee dossiers and compliance with Anvisa requirements.
Description
- Lead the regulatory affairs team, develop analysts, set priorities, track performance, and ensure work meets deadlines, legal requirements, and department standards.
- Coordinate with Anvisa and internal and external stakeholders, tracking regulatory developments and identifying ways to improve company processes and strategies.
- Improve regulatory processes through continuous improvement and digital transformation.
- Advise the team and strategic projects on technical and regulatory matters, assessing risks and requirements from planning through implementation.
- Connect teams across the company to maintain regulatory alignment and inform business decisions.
- Report regulatory portfolio metrics, risks, priorities, and status to management to support decisions and strategy development.
- Set and track KPIs and improvement initiatives to strengthen efficiency, delivery predictability, and regulatory risk management.
- Represent the department in internal and external forums, contributing to strategic discussions with industry associations, Anvisa, and company leadership.
Requirements
- Bachelor’s degree in Pharmacy.
- In-depth knowledge of current Anvisa health regulations, including RDCs, Normative Instructions, guidelines, and other standards covering the pharmaceutical product lifecycle.
- Extensive Regulatory Affairs experience across pharmaceutical product categories, including regulatory strategy, classification, and lifecycle management such as post-approval changes, marketing authorization renewals, GMP certification (CBPF), HMP, and related activities.
- Experience preparing post-approval dossiers and maintaining compliance and traceability for submissions to Anvisa.
- Experience coordinating cross-functional work, tracking submissions and regulatory deadlines, and managing portfolios.
- Intermediate English, sufficient to lead meetings, work with international partners, and review technical documents.
- Knowledge of Excel and regulatory intelligence.
- Intermediate Spanish is an advantage.
- Knowledge of CTD is an advantage.
Benefits
- Medical and dental insurance.
- Aché and Biosintética medications at no cost for employees and eligible dependents.
- Preventive examinations with no copayment.
- On-site medical appointments and diagnostic sample collection.*
- Wellhub (formerly Gympass).
- “Estar Bem Aché,” an integrated health program supporting the mental, physical, social, financial, occupational, and intellectual well-being of employees and eligible dependents.
- Support programs for pregnant employees and pregnant or postpartum spouses.
- Scholarship partnerships and educational discounts at various institutions.
- Profit-sharing program (PPR).
- Private pension plan with 1:1 employer matching.
- On-site restaurant and meal allowance.
- Transportation allowance, parking, or company shuttle.*
- Childcare allowance or exclusive on-site daycare at the Guarulhos facility.
- Exclusive Short Friday program for administrative positions at the Guarulhos facility.
- Christmas gift.