Senior Regulatory Affairs Manager

7 dni temu


Gdańsk, Pomerania, Polska LEO Pharma Pełny etat
About LEO Pharma

As a global leader in medical dermatology, LEO Pharma is committed to making a lasting impact on the lives of patients worldwide. Our innovative approach sets us apart, and we are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.

Job Description: Regulatory Process and Compliance Senior Professional

This role requires a seasoned regulatory affairs professional with a passion for driving regulatory process optimization and compliance. As a Regulatory Process and Compliance Senior Professional, you will lead, drive, and coordinate the development, maintenance, and optimization of global regulatory processes.

Your main tasks will include:

  1. Leading the development and maintenance of global regulatory procedures and process documentation.
  2. Providing strategic guidance and support to cross-functional teams on regulatory processes and compliance.
  3. Ensuring adherence to quality management systems and relevant legislation.
  4. Driving process improvements through periodic reviews and identifying areas for enhancement.
  5. Coordinating audits and inspections, ensuring compliance with regulatory requirements.
  6. Staying current with regulatory guidelines and requirements and communicating updates to relevant stakeholders.
  7. Collaborating with internal and external partners to ensure compliance with regulatory processes and requirements.
  8. Facilitating and participating in process improvement initiatives and contributing to the development of best practices.
  9. Nurturing a quality mindset culture by promoting and communicating lessons learned and best practices.
Requirements

To succeed in this role, you will have:

  1. A Bachelor's or master's degree in a relevant scientific discipline.
  2. A minimum of 8 years of experience in regulatory affairs, with a focus on process management and compliance.
  3. Strong knowledge of regulatory guidelines and requirements.
  4. Solid experience in driving and implementing process optimizations within R&D in the pharmaceutical industry.
  5. Experience in developing and maintaining quality management systems.
  6. Experience of Partners Agreements for regulatory affairs tasks and activities.
  7. Experience with driving and leading projects.
  8. Excellent communication and stakeholder management skills.
  9. A proactive can-do attitude to achieve long-lasting results and secure end-to-end thinking.
  10. Strong organizational skills with attention to detail and ability to work in a fast-paced environment.
  11. Strong analytical and problem-solving skills.
  12. The ability to work independently and as part of a team.
  13. Flexibility and adaptability to navigate changing regulatory landscapes.
  14. Fluency in English.


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