REGULATORY AFFAIRS SPECIALIST (OTC)

Adamed; Polska; Híbrido; PLN 120.000 - 180.000; Jornada completa

Descripción de la vacante

Adamed in Poland is seeking a Regulatory Affairs professional to manage and monitor registration activities for new products, ensure ongoing validity of marketing authorisations, and coordinate with authorities to obtain market approvals.

The role requires a science degree, 2-3 years in medicinal product registration, strong English, knowledge of Polish/EU law, and proficiency with MS Office, with timely, accurate documentation.

Formación

• University degree in pharmacy, biotechnology, chemistry, biology or a related field.
• 2-3 years of professional experience in medicinal product registration.
• Very good command of written and spoken English.
• Knowledge of Polish and European pharmaceutical law, directives, regulations and guidelines concerning dossier requirements and medicinal product registration.
• Knowledge of regulations governing registration or notification of medical devices, food supplements and cosmetic products would be an additional advantage.
• Proficiency in MS Office.

Responsabilidades

• Managing and monitoring registration activities for new products in accordance with the arrangements made by the Project Management Department/PMB.
• Managing and monitoring processes related to maintaining the validity of marketing authorisations, in line with the established timelines and approved budget.
• Managing and monitoring notification and/or submission processes with the relevant regulatory authorities to obtain the right or authorisation to market food supplements, medical devices and cosmetic products, in line with the established timelines and approved budget.
• Preparing regulatory documentation in accordance with country-specific requirements for registrations, renewals and post-approval variations.
• Cooperating with regulatory authorities, archiving regulatory documentation in accordance with the established system, and entering data into the BPM database.
• Responding to questions and comments raised by regulatory authorities within the scope of the Regulatory Affairs Department’s responsibilities during registration, renewal and post-approval variation procedures, including active cooperation with other organisational units involved in these processes.
• Ensuring that regulatory documentation remains accurate and up to date.
• Commissioning the preparation of expert reports, analyses and additional documents required for regulatory procedures.
• Collecting regulatory guidelines and continuously developing regulatory knowledge of EU and non-EU markets.
• Completing assigned tasks accurately and on time, in accordance with instructions and guidance provided by supervisors.
• Preparing key input data for the development of regulatory strategies, including budgets and timelines.
• Conducting audits of product regulatory documentation.

Conocimientos

Regulatory affairs

English fluency

Educación

University degree in pharmacy or related field

Herramientas

MS Office

Descripción del empleo

• Managing and monitoring registration activities for new products in accordance with the arrangements made by the Project Management Department/PMB.
• Managing and monitoring processes related to maintaining the validity of marketing authorisations, in line with the established timelines and approved budget.
• Managing and monitoring notification and/or submission processes with the relevant regulatory authorities to obtain the right or authorisation to market food supplements, medical devices and cosmetic products, in line with the established timelines and approved budget.
• Preparing regulatory documentation in accordance with country-specific requirements for registrations, renewals and post-approval variations.
• Cooperating with regulatory authorities, archiving regulatory documentation in accordance with the established system, and entering data into the BPM database.
• Responding to questions and comments raised by regulatory authorities within the scope of the Regulatory Affairs Department’s responsibilities during registration, renewal and post-approval variation procedures, including active cooperation with other organisational units involved in these processes.
• Ensuring that regulatory documentation remains accurate and up to date.
• Commissioning the preparation of expert reports, analyses and additional documents required for regulatory procedures.
• Collecting regulatory guidelines and continuously developing regulatory knowledge of EU and non-EU markets.
• Completing assigned tasks accurately and on time, in accordance with instructions and guidance provided by supervisors.
• Preparing key input data for the development of regulatory strategies, including budgets and timelines.
• Conducting audits of product regulatory documentation.
• University degree in pharmacy, biotechnology, chemistry, biology or a related field.
• 2-3 years of professional experience in medicinal product registration.
• Very good command of written and spoken English.
• Knowledge of the structure and content of medicinal product registration dossiers.
• Knowledge of Polish and European pharmaceutical law, directives, regulations and guidelines concerning dossier requirements and medicinal product registration.
• Knowledge of regulations governing the registration or notification of medical devices, food supplements and cosmetic products would be an additional advantage.
• Proficiency in MS Office.