Regulatory Consultant
4 weeks ago
Regulatory Affairs at Leaman Life Sciences
**Job Summary**
We are seeking a highly motivated and experienced Regulatory Consultant to join our team at Leaman Life Sciences. As a key member of our Regulatory Affairs team, you will play a crucial role in providing strategic, technical, and regulatory advice to our clients in the non-clinical development of human medicinal products.
**Key Responsibilities**
* Provide innovative drug development plans, data gap analyses, and international regulatory strategies from a non-clinical perspective for complex products within the changing regulatory environment.
* 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, including Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, IMPDs, CSRs, MAAs, NDAs BLAs, Scientific Advice, and Meeting Briefing Documents.
* Lead multi-jurisdiction programs of work and deliver consulting services within your respective 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/or future projects, contracts, or new business opportunities.
* Support the Business Development team in sales/marketing introductions and generate additional business from current clients.
* Line manage, train, and mentor members of the Operational team, including 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 (Principal Consultant) or minimum eight years of experience (Senior Consultant).
* A minimum of ten years of experience (Principal Consultant) or a minimum of eight years (Senior Consultant) with either FDA, MHRA, and/or EMA, including negotiation.
* Experience with recombinant proteins (including antibodies), prophylactic and therapeutic vaccines, biosimilar products, advanced therapy medicinal products (tissue, cell, and gene therapy), and NCE and/or generic chemical entities.
* Direct experience preferred in providing strategic regulatory planning from early-stage development up to marketing authorisation, and a proven ability to define and deliver creative scientifically driven solutions to technical development and regulatory issues.
* Proven ability and willingness to lead a team and deliver education and training in chosen field, both internally and at scientific conference presentations.
**What We Offer**
* A competitive salary and benefits package.
* Opportunities for professional growth and development.
* A dynamic and supportive work environment.
* Flexible working arrangements, including remote work options.
**How to Apply**
If you are a motivated and experienced Regulatory Consultant looking for a new challenge, please submit your application, including your CV and a cover letter, to [insert contact information].
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