Senior Regulatory Affairs Manager
7 dni temu
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 ProfessionalThis 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:
- Leading the development and maintenance of global regulatory procedures and process documentation.
- Providing strategic guidance and support to cross-functional teams on regulatory processes and compliance.
- Ensuring adherence to quality management systems and relevant legislation.
- Driving process improvements through periodic reviews and identifying areas for enhancement.
- Coordinating audits and inspections, ensuring compliance with regulatory requirements.
- Staying current with regulatory guidelines and requirements and communicating updates to relevant stakeholders.
- Collaborating with internal and external partners to ensure compliance with regulatory processes and requirements.
- Facilitating and participating in process improvement initiatives and contributing to the development of best practices.
- Nurturing a quality mindset culture by promoting and communicating lessons learned and best practices.
To succeed in this role, you will have:
- A Bachelor's or master's degree in a relevant scientific discipline.
- A 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.
- A proactive can-do attitude to achieve long-lasting results and secure end-to-end thinking.
- Strong organizational skills with attention to detail and ability to work in a fast-paced environment.
- Strong analytical and problem-solving skills.
- The ability to work independently and as part of a team.
- Flexibility and adaptability to navigate changing regulatory landscapes.
- Fluency in English.
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