Senior Regulatory Expert
3 weeks ago
We are seeking a highly motivated Regulatory Consultant (Non-Clinical) Leader to join our team at Leaman Life Sciences.
This role offers a superb opportunity for growth and development, playing a key role within our team and contributing to the success of our Regulatory Consultancy.
The successful candidate will provide high-quality regulatory technical advice and product development strategies for our clients, working closely with our team to develop and mentor staff.
Key Responsibilities:
- Provide strategic, technical, and regulatory advice and services to clients with a special interest in non-clinical development of human medicinal products.
- Develop and implement innovative drug development plans, data gap analyses, and international regulatory strategies from a non-clinical perspective.
- Establish and maintain a high level of technical knowledge within product development and international regulatory affairs.
- Represent clients in all regulatory agency interactions and provide regulatory solutions to agency objections.
- Contribute to technical authorship and review of development regulatory documents.
- Lead multi-jurisdiction programs of work and deliver consulting services within the area of expertise.
- Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
- Lead meetings with stakeholders on matters related to current and future projects, contracts, or new business opportunities.
- Support the Business Development team in sales and marketing introductions and generate additional business from current clients.
- Line manage, train, and mentor members of the Operational team, providing technical leadership.
Requirements:
- A high scientific calibre with a life science focused BSc or equivalent, and a higher degree in a biomedical field or equivalent.
- A minimum of ten years of drug development experience, with direct experience in providing strategic regulatory planning.
- Experience with either recombinant proteins, prophylactic and therapeutic vaccines, biosimilar products, advanced therapy medicinal products, and NCE and/or generic chemical entities.
- Proven ability to lead a team and deliver education and training in the chosen field, both internally and at scientific conference presentations.
This role requires flexibility and a willingness to work from our office in Hertfordshire and travel for short periods within the country or internationally, with a minimum of one day per month.
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