Senior RA Strategy Professional

Application deadline:  
Location: Gdansk 80-309, Poland, Poland 
Contract type: Permanent 
Job ID: 2974 

Are you an experienced professional with a passion for regulatory affairs? LEO Pharma is seeking a talented Senior RA Strategy Professional to join our team. As a Senior Regulatory Professional, you will play a pivotal role in developing and executing regulatory strategies for our innovative products in development.  If you have a strong background in regulatory affairs, excellent strategic thinking skills, and a commitment to excellence, this is the opportunity for you to make a significant impact in the field!

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 Senior RA Strategy Professional, your objective will be to shape the future of regulatory affairs by developing and implementing regulatory strategies, ensuring compliance with global regulations, and driving innovation in the field. You will play a critical role in guiding the organization through complex regulatory landscapes and contributing to the success of our products.
 
Your main tasks will be to:
•    Develop and implement regulatory strategies to support product development and commercialization.
•    Collaborate with cross-functional teams to ensure alignment of regulatory strategies with business objectives.
•    Perform regulatory review of clinical and nonclinical documents for submissions, e.g., clinical protocols and study reports, preclinical reports, investigator brochures.
•    Lead global filing activities for submissions
•    Prepare health authority interactions, including leading the cross-functional team through creation of briefing materials and meeting preparation
•    Present regulatory strategies including communication of regulatory risks and associated mitigation plans to management and other internal stakeholders
•    Stay up-to-date with evolving regulatory landscapes and assess the impact on the organization.
•    Collaborate with global regulatory teams to ensure alignment and consistency in regulatory strategies.

Your qualifications 
To succeed in this role, we imagine that you have the following qualifications:

•    A Master’s degree in natural science or equivalent.
•    Over 8 years of regulatory experience, with global markets incl. EU and achievement of major regulatory milestones, including drug development milestones (e.g., CTA, pre-IND, Health Authority interactions) 
•    Proven track record of successful regulatory submissions and approvals, preferably in the EU, US, and China.
•    Proficient in interpreting scientific data and applying it to regulatory strategies.
•    Project management qualifications/experience.
•    Excellent verbal and written communication skills
•    Advanced understanding of the drug development/LCM process, regulatory activities, and Health Authority interactions.
•    Expert knowledge of regulatory guidelines and strategic regional considerations.
•    Strong strategic and global mindset
•    Organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
•    A quality mind set and able to prioritize your work in a fast paced and changing environment.
•    Ability to thrive in a busy environment and maintain a positive attitude under pressure

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.
You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.

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. 
Join us on our journey Beyond the Skin. Apply today! 

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.