Head Of Regulatory Affairs

Our client is a rapidly growing niche pharmaceutical services company operating in four key sectors: Managed Access Programs (MAP), Unlicensed Medicines Access, Clinical Trial Sourcing and Reference Product Supply. Operating international the leadership team has many years of pharmaceutical experience working for household names. The company have robust systems and are regulated to a level where they can handle controlled substances. Customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. They are looking to hire a Global Regulatory Lead to be a point of contact with the Regulatory Authorities.

Role:

Head Of Regulatory Affairs will report to the Managing Director EU. The role will be responsible for understanding, developing and managing the regulatory strategy for Expanded Access (EAP), Compassionate Use (CUP) and Named Patient (NPP) progammes.

Responsibilities:

Responsible for understanding the EAP, CUP and NPP regulatory landscape

Reviewing and maintaining the regulatory database

Lead Regulatory strategy and operational advice to clients

Provide regulatory strategies, writing and review of internal and external documentations to support programs

Support senior management and business development teams to implement the right regulatory approach for customers

Main point of contact for internal and external regulatiry expertise

Knowledge & Skills:

• Ideally degree level education or practical experience in a healthcare setting
• Either Biotech or Pharmaceutical industry in a Regulatory capacity
• Leading client and health authority interactions
• Writing and reviewing regulatory documents

Regulatory strategy

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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales