Global Regulatory Affairs Lead Blackfield is pleased to be supporting the continued expansion of an international pharmaceutical company with a strong portfolio of established and acquired medicines as well as clinical assets. We are looking for experienced CMC professionals and RA leads with Central nervous system experience. As GRL, you will: Develop and drive the implantation of both regional and global regulatory strategies for a broad portfolio, including premarket and marketed/ established products Point of contact for health authorities and regulated bodies Roadmap and horizon scanning for upcoming regulatory changes or global events that could impact the business Working in a cross -functional team, alongside Quality, commercial and scientific departments Act as Global Regulatory leader- reporting to the company KOL’s or SLT; answering any queries from notified bodies and leading how best the company is to act. To be considered for the role of Global Regulatory Affairs Lead, you will have: Educated to degree level in a relevant scientific field Extensive experience in regulatory affairs at global level- either ROW, EU, or LATAM Minimum 10 years of experience in regulatory affairs, ideally at a senior level of Lead or associate director Proven track record leading global submissions across the product lifecycle, with knowledge of safety variations Extensive CMC lifecycle management and licence variations Excellent communication and stakeholder management skills, including client-facing interactions Portfolio experience in CNS, Rare disease, infectious disease, Ophth or neuro Previous experienced gained in a big pharma would be desirable but not mandatory Ideal candidates would have Neuroscience background and some knowledge of clinical guidelines This is a permanent position, working hybrid from our clients Slough office. Unable to sponsor, candidates must hold a valid right to work.