Our client, a continually expanding healthcare company is looking for a senior Regulatory director to join their team on an initial six-month assignment, to develop, lead and establish their regulatory strategy across lifecycle and new development assets.The information below covers the role requirements, expected candidate experience, and accompanying qualifications.As Senior Regulatory Director, you will:Leading the development and implementation of innovative regulatory strategy, globally, whilst ensuring compliance with local and international regulations.Building recommendations for the leadership team based on best practice, changing our current ways of working and advising the right systems to support business growth.Partnering with the business as a strategic partner/advisor to help achieve company objectives including due diligence activities.Overseeing and contributing to the preparation, submission, and management of regulatory documents (INDs, NDAs, MAAs, post approval variations etc.) Acting as the primary liaison with regulatory bodies, driving communications, and maximise the likelihood of timely approvals.Enhance cross-functional communication with in house and external partners to assure alignment with regulatory strategy.Lead and build the regulatory team to develop the knowledge, skills and capabilities to effectively deliver the business strategy. Maintain contemporary knowledge of global regulations and ensure effective knowledge sharing across the business.Identifying potential regulatory risks and developing mitigation strategiesTo be considered as the Senior Regulatory Director, you will:Educated to Masters or similar level in a relevant scientific field such as Chemistry, biology, pharmacy or life sciencesExtensive, broad experience in global regulatory affairs within the pharmaceutical, biotech, medical device industry is essential – this role will suit a fast paced, dynamic individual with an entrepreneurial approachMust have leadership experience of at least 4 direct reports, in a highly cross-functional businessDirect / proven experience working with / leading meetings with regulatory authorities including MHRA, EMA and exposure to FDA is highly desirableThis role is suitable for a hands on, fast-paced regulatory leader / doer. This is a role for a candidate to bring experience to maximise an opportunity for growth; Due to the nature of business, candidates must be located within a reasonable commute and be present in the office on a hybrid/ 3 days per week basis.
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