Survey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country.
Responsible for the review, analysis and filing of new records before the regulatory entity in each country.
Responsible for renewals and monitoring of health records.
Responsible for responding to the requests or requirements of the territorial entities or legal entities that have any need for information, complaint or disagreement with the products and manufacturing processes.
Responsible for updating regulatory legislation for the countries in charge at the level: technical, regulatory, quality, pharmacovigilance and marketing.
Guarantee those responsible for handling medicines the application of good manufacturing practices (GMP)
Coordination of brands, dossiers and patents within the company
Take charge of product quality issues in the company's internal and external processes ex : complaints, Discussion with ANVISA, etc
Manage internal and external processes such as: trades, paperwork, stock depletions for the areas of regulatory affairs and quality.
Guarantee the updating of the BPM, BPL systems regarding: sanitary records, technical sheets, safety sheets and commercial information.
Manage communication and coordination with the manufacturer for certificate procedures.
Comply with the documentation and information provided by the Head Office in India vs. the related information of each health registry in the countries in charge.
Responsible for the review of packaging and its materials to ensure compliance with regulations in each territory.
Coordination with the quality area of ??the logistics operator of the packaging for additional coding processes, packaging changes, inclusion of inserts.
Co ordinating with responsible PV person to be align with regulatory requirement
Delegating work to the regulatory affairs team for smooth operations with respect to submissions and life cycle management of the drug product.Knowledge and functional skills to exercise the position:
Experience of 5 to 10 years in the industry of pharmaceutical products for human use.
Pharmaceutical chemist professional.
Knowledge of regulatory affairs and quality requirements per regulatory requirement.
Requirement for dossier submissions for different dosage forms like tablets, Injections and oral solutions. Have complete update knowledge on the RDC's and application of the same.