Aché Laboratórios este un producător farmaceutic brazilian cu aproape șase decenii de experiență în dezvoltarea, producerea și comercializarea medicamentelor eliberate pe bază de rețetă și fără rețetă. Portofoliul său include, de asemenea, medicamente generice, dermocosmetice și suplimente nutraceutice, deservind atât profesioniștii din domeniul sănătății, cât și consumatorii. Compania îmbină cercetarea farmaceutică și dezvoltarea produselor cu producția la scară largă, parteneriate comerciale în întreaga Brazilie, farmacovigilența, conformitatea cu cerințele de reglementare și inițiativele de sustenabilitate, inclusiv certificările ISO și eforturile pentru neutralitatea emisiilor de carbon.
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.
Descriere
- 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.
Cerințe
- 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.
Beneficii
- 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.