Senior Regulatory Affairs Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €51,718 - €61,000

Job Description:

Regulatory Affairs Manager CMC (Global)

We are seeking an experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs function, you will be responsible for ensuring compliance with regulatory requirements and guidelines related to medicinal products.

The ideal candidate will have hands-on experience in CMC authoring, as well as a solid understanding of development and commercial activities and cGMPs. They will also possess technical, functional, and industry knowledge to shape strategic direction and reduce regulatory burden.

  • Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with global regulations;
  • Prepare and deliver high-quality CMC regulatory submissions;
  • Manage regulatory issues and maintain submission information in relevant systems;
  • Collaborate with cross-functional teams to achieve business objectives;

Required Skills and Qualifications:

  • Hands-on CMC authoring experience;
  • Strong understanding of regulatory requirements and expectations;
  • Technical, functional, and industry knowledge;
  • Ability to develop and implement effective regulatory strategies;

Benefits:

We offer a competitive salary and benefits package, as well as opportunities for career growth and professional development. Our company values diversity and inclusion, and we strive to create a work environment that is respectful and supportive of all employees.

Others:

At our company, we are dedicated to making a positive impact on the lives of others. We believe that our diverse perspectives and experiences make us stronger, and we encourage all qualified candidates to apply.

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