REGULATORY AFFAIRS SPECIALIST (OTC)

ADAMED; Pieńków; Presencial; PLN 90.000 - 120.000; Jornada completa

Descripción de la vacante

Adamed is seeking a Regulatory Affairs professional to manage registration activities for new products and maintain marketing authorisation dossiers in Poland and the EU. The role requires collaboration with regulatory authorities, preparation of regulatory documents, and ensuring compliance with timelines and budgets.

The ideal candidate has a pharmacy-related degree, 2–3 years of medicinal product registration experience, strong English skills, and knowledge of Polish and EU pharmaceutical

Formación

• Knowledge of EU and Polish pharmaceutical law, directives, regulations and dossier requirements.
• Strong written and spoken English.
• Experience with medicinal product registration processes.

Responsabilidades

• Manage and monitor registration activities for new products as per PMD timelines and budget.
• Maintain validity of marketing authorisations within established timelines and budget.
• Coordinate notification/submission processes with regulatory authorities for market authorisation.
• Prepare regulatory documentation for registrations, renewals and post-approval variations.
• Collaborate with authorities, archive documents, and input data into BPM database.
• Respond to queries from authorities during registration, renewal and variations.

Conocimientos

English proficiency

Regulatory dossiers

EU/Poland regulations

MS Office

Regulatory strategy support

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.