Job Description
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