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.
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.)
to health authorities like the MHRA, FDA, EMA, and others.
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.
Build a culture of trust and communication so that the team can deliver to the best of their ability.
Maintain contemporary knowledge of global regulations and ensure effective knowledge sharing across the business.
Identifying potential regulatory risks and developing mitigation strategies To 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 sciences Extensive, 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 approach Must have leadership experience of at least 4 direct reports, in a highly cross-functional business Extensive knowledge and hands on of preparing and maintaining dossiers for clinical trials and marketing authorizations Direct / proven experience working with / leading meetings with regulatory authorities including MHRA, EMA and exposure to FDA is highly desirable Deep GxP knowledge is essential This 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; a commercially astute professional.
For more information, contact Rob Carnell at Blackfield Associates.
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.
No Sponsorship/INSIDE IR35