Director of Regulatory Affairs

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 qualifications:

• Must have significant experience of managing lifecycle regulatory activities for established products including new therapeutic indications and safety variations impacting SmPC and Package Leaflet
• Educated to advanced degree level in a life science discipline
• Expert knowledge of regulatory affairs in CNS and Ophthalmology therapeutic areas
• Sound knowledge of Quality and Clinical guidelines in EU and the UK
• Prior hands-on experience of leading technology and marketing authorisation transfer in EU
• Proven hands-on experience with EU regulatory procedures, especially MRP/DCP/CP and NP
• Must be hands on, authoring and lifecycle dossier submissions
• Well versed in CMC and clinical variation classifications and submission requirements
• Ability to think strategically within a complex business critical and high profile established product

This is a full time permanent position, working Hybrid working – 3 days a week from the office in Windsor.