Senior Director Regulatory Affairs

Blackfield Associates are partnered with a global pharmaceutical company who are looking to hire a strategic leader; senior director of regulatory affairs who will provide oversight and management across their global regulatory activity. This is a perfect opportunity for someone with a vision to become a VP of Regulatory.

As Senior Director of Regulatory, you will be responsible for:

• Oversight and leadership of strategy implementation globally, developing aligned to the companies local and international compliance requirements
• Leading the Regulatory function/ its team as a hands-on people manager
• Identifying and training the team to identify possible risks and implement mitigation strategies across the portfolio
• Point of contact for regulatory bodies such as the MHRA, FDA and EMA
• Oversee and assist in creating the companies’ key regulatory filling/ submissions, including INDs, NDAs, and MAA’s.

To be considered for the role of Senior Director Regulatory Affairs, you must have the following experience or attributes:

• Held senior management positions, ideally oversight of entire team/ function
• Extensive, 15 years plus technical experience in Regulatory Affairs in areas such as Rare Disease, Infectious Disease, Oncology, CNS, Cardiovascular, or Respiratory
• Proven industry experience within Biologics is essential
• Direct FDA experience, either with submissions or leading scientific advice meetings; with a network or knowledge on how to lead interaction with the agency
• Demonstrable leadership of regulatory strategy in EMA
• Extensive knowledge of preparing and maintaining dossiers for clinical trials and marketing authorisation

This is a permanent position with a growing business based in the UK. Onsite presence will be required frequently, at the company’s European HQ, located near London.

Unable to Sponsor applicants. Salary and package based on candidate experience and requirements.