Job Description
Blackfield Associates are further supporting a growing international pharmaceutical company who, due to continued growth and portfolio expansion are looking for Regulatory Affairs Director to oversee an Established Products portfolio, ensures compliance with regional and global regulatory requirements for existing and newly acquired products, develops and implements regulatory strategies, leads interactions with regulatory agencies and manages a regulatory team. Drives strategic planning based on European and UK regulatory guidelines for CNS and Ophthalmology drugs.
As Regulatory Affairs Director, you will be responsible for:
* Develop and implement regional and global regulatory strategies for established products
* Lead and manage interactions with regulatory authorities
* Full Regulatory Lifecycle management
* Accountable for compliance by adhering to internal processes and external regional regulatory requirements
* Define the strategy to address regulatory changes in global markets and share knowledge
* Lead and coach Regulatory Professionals: make feedback to develop team members, define clear objectives for the team in alignment with company goals, make responsible decisions to drive performance
To be considered for the role of Regulatory Affairs Director, you will have the following experience and...