Local Regulatory Affairs Head
Currently we are looking for a person for the position: Local Regulatory Affairs Head
Place of work: Warsaw
Tasks and responsibilities:
- Processes (as allocated to the individual team members)
- Provide input to Global RA, Local and ROPU RA concepts/strategies/projects
- Regulatory Intelligence: Foster close relationships with relevant Authorities and other key stakeholders
- Communication & impact assessment on new requirements
- Maintain allocated databases
- Share best practices within the OPU
- Compliance
- Ensure adherence to BI and international compliance rules as well as to local legislations in allocated areas of Regulatory Affairs
- Constant tracking of all compliance parameters for allocated products and processes (KPls)
- Marketing Support
- Preparation of short version of Summary of Product Characteristics
- Responsibility for RA budget planning and spending
- Ensure all Non-Compliances are reported and followed up
- Managing local Regulatory Affairs team consisted of two experts
About our future employee:
- University scientific degree
- Knowledge of local and international regulatory affairs regulation
- Relevant experience in pharmaceutical industry/CRO is an asset
- Good command of English language
- Organisational and communication skills
- Proactive attitude
- Team- and networker
- Thoroughness
- Strategic thinking
- Ability to judge a case
- Ability to lead & learn
What we offer:
In this position, we offer employment based on a contract of employment, great possibilities of development and a bonus system.
Additionally, we offer:
- Remuneration adequate to the level of experience and competence
- Independence in daily activities
- Company car, phone, laptop
- Opportunities for improvement and professional development
- Package of non-salary benefits (medical care, life insurance, Multisport card, My Benefit cafeteria)
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