Regulatory Affairs Director
This role plays a pivotal part in upholding professional excellence, regulatory adherence, and quality within the organization. As Regulatory Affairs Director, you will be responsible for overseeing RA projects at our Ireland site, leading regulatory procedures, and communicating with relevant stakeholders.
Responsibilities:
* Act as the primary point of contact for critical regulatory matters.
* Manage a team of Regulatory Affairs professionals.
* Lead interactions and formal communications with governmental agencies.
* Participate in departmental budget planning and execution.
* Oversee a significant regulatory affairs portfolio.
You will also drive RA developments, establishment, and improvement across our Ireland and Germany sites. Additionally, you will represent the company at regional and global regulatory strategy forums and negotiations.
Requirements:
* Masters degree in Science or related field.
* Experience with at least one major marketing application.
* In-depth knowledge of evolving regulatory requirement trends.
* Good understanding of complex biologics manufacturing science.
* Excellent project management skills.
* Minimum of 10 years pharmaceutical industry experience.
Benefits:
* Leadership opportunities.
* Quality assurance expertise.
* Compliance management skills.
* Organizational leadership abilities.
* Stakeholder engagement expertise.
Additional Requirements:
Fluency in English and German is desired. You should be able to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of an exciting journey towards accomplishing our mission.