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Director | Marketing & Sustainability | Volunteer Speaker | Fundraiser
About PDI International
PDI International is a private family-owned company with a 40-year heritage dedicated to leading the fight against preventable infections in healthcare, hospitality and our communities internationally. Through our dedication to research and development, sustainable innovation and industry-leading partnerships, we continue to build our portfolio of products and solutions, and help our customers by providing continual support, resources & expertise to help make a difference in the world.
PDI International serves its customers across three main divisions: PDI Healthcare, Sani-Professional, and PDI Contract Manufacturing.
About the Role
The Regulatory Specialist will be responsible for developing and managing our regulatory strategy, maintaining compliance across our product range, and working closely with teams across Quality, R&D and Operations. The work is varied – from managing regulatory submissions and inspections, to staying up to date with changing legislation and providing guidance across the business.
Key Responsibilities
* Develop and oversee a robust regulatory strategy in line with all applicable regulations and standards.
* Establish and manage regulatory submissions and maintain regulatory documentation.
* Liaise with regulatory authorities and respond to inquiries.
* Implement regulatory programs, working closely with the Quality (site QP), R&D and Operations.
* Interpret and apply regulatory guidelines to business operations.
* Conduct regulatory Risk Assessments where applicable.
* Prepare and review regulatory documents and reports.
* Participate in regulatory inspections and audits.
* Maintain a regulatory database and track regulatory activities.
* Ensure that all regulatory activities are documented and archived.
* Provide input as required on technical matters.
* Ensure all pharmacovigilance actives are managed and communicated effectively
* Collaborate with cross-functional teams to implement security measures, such as surveillance systems and access controls, to safeguard pharmaceutical inventory.
* Stay up-to-date with relevant pharmaceutical industry regulations, quality standards, and best practices.
* Ensure that the company’s operations comply with all applicable local, national, and international regulations.
* Provide regulatory training to staff.
* Foster a culture of quality and safety awareness among all staff members.
Key Requirements
* Bachelor’s degree in a relevant field; advanced degree (e.g., MBA, MSc) preferred.
* Extensive experience (10+ years) in Regulatory Affairs in the pharmaceutical industry.
* Strong understanding of pharmaceutical regulations and quality standards (GDP, GMP) in European markets.
* Proven track record of successfully implementing regulatory strategy and global registrations.
* Excellent leadership, communication, and interpersonal skills.
* Analytical mindset with the ability to make data-driven decisions.
Required Behaviours
* Flexible/adaptable
* Quality aware
* Respect for colleagues
* Team player
* Active
* Self-motivated
* Reliable and dependable
* Professional manner
* Diplomatic
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Medical Device
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