Regulatory Affairs Manager Poland & Baltics
Regulatory Affairs Manager as a member of local Management Team, reporting directly to General Manager plays a key role in regulatory affairs, quality and drug safety processes management. He or she is responsible for Poland, Baltics and Ukraine.
Client Details
Our Client is leading, international biopharmaceutical company offering cutting-edge therapies in highly specialised fields in over 100 countries worldwide. They foster the research and development investments towards finding innovative, complex and personalised healthcare solutions.
Description
- Preparing and submitting the registration documents to the competent authorities
- Approving designs of packaging, leaflets and serving as compliance advisor on promotion materials
- Budget management
- Acting as Local Safety Officer responsible for processing the information about adverse reactions/events and other pharmacovigilance related issues
- Submitting reports to the competent authorities
- Organising pharmacovigilance training for all employees in the entrusted geographic area
- Serving as focal point who closely cooperates with global Quality Assurance teams in case of any critical situations
- Notifying local authorities, distributors and clients about the agreed product withdrawal strategy
- Coordinating local complaints about reported deviations (i. e. transport and temperature)
- Creating and updating local Quality Assurance operating procedures based on global guidelines and local adjustments
- Monitoring and ensuring all regulatory affairs, PV and quality activities performed in Baltic states and Ukraine by external providers are in line with company's procedures and local law
Profile
- Minimum 10 years experience in pharmaceutical industry, including proven track record on independent Regulatory Affairs role with good understanding of Quality Assurance and PV
- Master degree in pharmaceutical, medical, biology, chemistry or related field
- Practical knowledge of Pharmaceutical Law and any regulations governing the registration of medicinal products, medical devices and food supplements on the Polish and European level
- Fluent English and computer literacy as a must-have
- Self-starter full of initiative and drive to bring solutions and make the things happen
- Ability to manage priorities with strong sense of urgency and flexibility
- Excellent influencing skills combined with collaborative approach to deal with multiple stakeholders
- Experience in conducting official correspondence with competent authorities
- Documented ability to operate in global, matrix structure and cross-functional teams on daily basis
Job Offer
- Strategic role in the organisation with local and global exposure and regional responsibility
- High working standards and vibrant international environment
- Significant empowerment within medium-sized innovative company
Please apply via the button on the right side of this job offer.
Job details
Location: Warsaw
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
More
Location: Warsaw
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
More
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