Senior Director/ Director
7 days ago
Superb senior role in Regulatory CMC Policy & Intelligence and a key hire for a dynamic and fast-growing Biopharma.
This outstanding role requires the candidate to provide EU Regulatory Intelligence expertise in order to steer the development and execution of Regulatory CMC Policy for the organisation.
Possessing good relationships with Trade Bodies - the EFPIA, and Regulatory Authorities - the EMA, MHRA and other European National Authorities along with other key internal and external stakeholders is essential to the role.
The ideal candidate will have operated in Regulatory CMC to a senior level prior to entering Regulatory Policy & Intelligence.
Identification of EU Regulatory Policy & Intelligence issues/trends/changes occurring in the market that have the potential to impact the company's productsActively engagement externally to shape the EU policy environment in line with the company's objectives
Commercial/Medical/Regulatory/Government Affairs etc. and actively engage externally to shape the EU policy environment in line with company priorities and objectives
Set policy agenda and engage directly in EU Regulatory advocacy and promotional activities
The candidate will set the agenda and collaborate with other Senior Management in relation to the company's positioning and statements on the external environment and prevailing issues.
Identify and respond to EU Regulatory/legislative policy issues that impact on R & D, Development, Registrations and Life-cycle Management.
Provide thought leadership in regard to in EU Regulatory policy and to and maintain/develop mutually beneficial relationships with key leadership at Regulatory Authorities.
If you are interested in this, or any other Regulatory Affairs roles, please contact Julian Turner, at Turner Regulatory Recruitment, on / , or by .
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