Regulatory Affairs Manager
3 meses atrás
- 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.
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