Product Development & Regulatory Affairs Manager
Η θέση δε δέχεται πλέον αιτήσεις
16-50
Φαρμακευτικές & Κλάδος Υγείας
πριν ένα μήνα
Ημ. ανάρτησηςπριν ένα μήνα
Με κάποια εμπειρίαΕπίπεδο εμπειρίας
Με κάποια εμπειρίαΠλήρης απασχόλησηΤύπος απασχόλησης
Πλήρης απασχόλησηΕπιστημονικός ΚλάδοςΚατηγορία θέσης
Επιστημονικός Κλάδος
ISOPLUS S.A demonstrates more than 30 years of experience and excellence in the representation, distribution and promotion of natural food supplements and cosmetics in Greece and abroad, possessing a leading position in the Greek market through an extensive sales network.
We are currently looking for a Product Development & Regulatory Affairs Manager to join our team in our Headquarters in Athens.
Main Responsibilities
- Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
- Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.
- Ensure that all regulatory requirements are met throughout the product lifecycle.
- Prepare and submit regulatory submissions, including but not limited to, product registrations, pre-market notifications, and post-market surveillance reports.
- Liaise with regulatory authorities and act as the primary point of contact during inspections, audits, and regulatory agency interactions.
- Conduct risk assessments and develop mitigation strategies to manage regulatory risks.
- Review and approve product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.
- Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory requirements are incorporated into the development process.
- Monitor and track regulatory compliance metrics and provide regular reports to senior management.
- Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.
Key Requirements
- Bachelor's degree in a scientific discipline, engineering, or related field. Master's degree is preferred.
- Minimum of 3-4 years of experience in regulatory affairs within the relevant industry.
- Proven track record of successfully developing and executing regulatory strategies and obtaining regulatory approvals for products.
- In-depth knowledge of relevant regulations and standards, such as FDA regulations, ISO standards, and other applicable regional regulations.
- Experience in interacting with regulatory authorities and managing regulatory inspections and audits.
- Professional certifications in regulatory affairs are a plus.
- Strong understanding of quality systems and the ability to apply regulatory requirements to quality management processes.
- Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation.
Benefits
- Competitive remuneration package
- Private health insurance
- Learning and development opportunities
- Modern and friendly working environment where teamwork, communication, improvement and reward are fundamental components
If you think you have what it takes, we are looking forward to hearing from you!
*All applications will be treated with strict confidentiality.
ΠΕΡΙΛΗΨΗ ΘΕΣΗΣ
Product Development & Regulatory Affairs Manager
Καλλιθέα
πριν ένα μήνα
Με κάποια εμπειρία
Πλήρης απασχόληση