Regulatory Affairs Expert

LDRA:

• Executes RA activities in line with defined procedures and processes.
• Obtain product registration dossiers from HQ Q&R and tailor them to meet country/region registration 
• requirements
• Implement processes involved with maintaining annual licenses, registrations, and listings
• Submit notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product 
• information and/or instructions for use to reflect current state of product knowledge
• Support and accelerate market access for our products in line with regulatory requirements, verticals and 
• commercial operations roadmap. Contribute to the Due diligences for in-licensing projects and to the preparation 
• of the launch for new development project for all regulatory aspects.
• Serve as the Regulatory point of contact on the assigned task(s) with local/regional management and/or at other 
• internal meetings providing the agreed global regulatory strategic recommendations and risk assessment for key 
• projects.
• Monitor, evaluate and inform key internal stakeholders about applicable national and hub regulatory 
• requirements; coordinate internal implementation and actively contribute to the development of new regulatory 
• requirements. 
• Perform all regulatory affairs activities in the hub including management of product complaints and product 
• regulatory conformity, safety, and post market systems as well as communication to applicable SysQaRa 
• functions in accordance with corporate SOPs 
• Perform based on established targets, KPIs and objectives for Q&R.

PVRP:

• Perform regular Pharmacovigilance processes and activities (including trainings). 
• Ensure that adverse events and product quality complaints are reported in compliance with corporate policies 
• and procedures.
• Lead the strategic planning and implementation of pharmacovigilance objectives in your country/region, including 
• department structure, processes, and local Health Authority policy implementation.
• Maintain the filing, storage, and archiving of safety-related documentation in accordance with company policies 
• and local requirements.
• Ensure audit / inspection readiness, coordinates, leads, and actively participates in local audits and inspections.
• Support Pharmacovigilance Agreements, when applicable.

FVP/GDP RP:

• Ensure that a Quality management system is implemented and maintained,
• Focus on the management of authorized activities (GDP) and the accuracy and quality of records.
• Ensure that initial and continuous training programs are implemented and maintained,
• Coordinate and promptly perform any recall operations for medicinal products,
• Ensure that relevant customer complaints are dealt with effectively,
• Ensure that suppliers and customers are approved,
• Approve any subcontracted activities which may impact on GDP
• Keep appropriate records of any delegated duties,
• Decide on the final disposition of returned, rejected, recalled or falsified products,
• Approve any returns to saleable stock
• Ensure that any additional requirements imposed on certain products by national law are adhered to

REQUIREMENTS:

• Scientific education such as Degree in Medicine, Pharmacy, Biology, Chemistry and/or related Engineering degree(s).
• Desirable 5 years professional experience in regulatory management of medicinal products respectively similar activity in the regulated 
• environment.
• Communicative, reliable, careful, conscientious, quality minded, detail oriented
• Regulatory and PV guidelines (EU, local)
• Switzerland: Therapeutic Products Act (TPA) Act, TPA)(Therapeutic Products Act, TPA)(Therapeutic Products Act, TPA)
• Austria: Medicinal Products Act (AMG)
• MDR/MDD
• GDP
• Microsoft Office, related MS applications
• Knowledge of German and English languague both in word and writing
• Good regulatory understanding
• Good communication skills