Regulatory Process and Compliance Senior Professional

Application deadline:  
Location: Gdansk 80-309, , Poland 
Contract type: Permanent 
Job ID: 3018 

Are you a seasoned regulatory affairs professional with a passion for driving regulatory process optimization and compliance? LEO Pharma is seeking a talented Regulatory Process and Compliance Senior Professional to join our team. If you have a strong background in regulatory affairs, process management, and a commitment to achieving regulatory excellence, this is the opportunity for you to make a significant impact in the pharmaceutical industry!

At LEO Pharma, our mission to go beyond the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world of opportunities!

Your Role

As a Regulatory Process and Compliance Senior Professional, your objective will be to lead, drive, and coordinate the development, maintenance, and optimization of global regulatory processes. In this role you will be key in ensuring our processes are following internal and external requirements, and that the processes at the same time support a flexible and agile working environment.
You will ensure adherence to quality management systems and relevant legislation, while providing strategic oversight and performing periodic reviews. Your role will also involve managing regulatory compliance, supporting audits and inspections, and maintaining regulatory process and quality management systems. 
Depending on your background we will strive to tailor the tasks to benefit your competencies and further development as well as the team in general.
 
Your main tasks will be to:
•    Develop and maintain global regulatory procedures and process documentation.
•    Act as Subject Matter Expert (SME) providing guidance/advice and support to cross-functional teams on regulatory processes and compliance.
•    Ensure adherence to quality management systems and relevant legislation.
•    Perform periodic reviews and identify process improvements.
•    Support audits and inspections, ensuring compliance with regulatory requirements.
•    Stay up to date with regulatory guidelines and requirements and communicate changes to relevant stakeholders.
•    Collaborate with internal and external partners to ensure compliance with regulatory processes and requirements.
•    Facilitate and participate in process improvement initiatives and contribute to the development of best practices.
•    Promote and nourish a quality mindset culture by proactively facilitate and communicate lessons learned and best practices in line of business.
We are offering a job with considerable individual responsibility and challenges, and a high level of visibility, as you will collaborate with a great number of stakeholders across the organization.

Your qualifications 

To succeed in this role, we imagine that you have the following qualifications:
•    Bachelor’s or master’s degree in a relevant scientific discipline
•    Minimum of 8 years of experience in regulatory affairs, with a focus on process management and compliance
•    Strong knowledge of regulatory guidelines and requirements
•    Solid experience in driving and implementing process optimizations within R&D in the pharmaceutical industry
•    Experience in developing and maintaining quality management systems
•    Experience of Partners Agreements for regulatory affairs tasks and activities
•    Experience with driving and leading projects
•    Excellent communication and stakeholder management skills
•    Pro-active can-do attitude to achieve long-lasting results and secure end-to-end thinking
•    Organized with strong attention to detail and ability to work in a fast-paced environment
•    Strong analytical and problem-solving skills
•    Ability to work independently and as part of a team
•    Adaptability and flexibility to navigate changing regulatory landscapes
•    Fluency in English

Your new team

We are an ambitious team driven by a high level of integrity, and passion for our work. We value a great collaborative atmosphere where you can always reach out to a colleague or manager for support and sparring.
 
Contact and application
At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this opportunity to build new areas in a land full of possibilities. 
 

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. 
 
At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.
 
For certain positions, LEO Pharma might complete a background check conducted by a third party.