Principal Consultant CMC UK
Principal Consultant CMC UK
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5years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Role
Scendea is seeking a highly motivated individual to join our global team as a fulltime Principal Consultant (CMC). This is a hybrid position affiliated to our UK Bishops Stortford office with a requirement to work in the office a minimum of one day per month.
This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy. You will have the opportunity to play a key role in the development and mentoring of staff whilst providing highquality regulatory technical advice and product development strategies for clients.
Requirements
Role Requirements
- Provide strategic technical and regulatory advice/services to clients with a special interest in CMC development of human medicinal products.
- Establish and maintain a high level of technical knowledge in product development and international regulatory affairs.
- Provide innovative drug development plans data gap analyses and international regulatory strategies from a CMC perspective for complex products within the changing regulatory environment.
- Contribute to technical authorship and review of development regulatory documents including Regulatory Strategy Plans Drug Development Plans Clinical Trial Applications PreINDs INDs Scientific Advice and Meeting Briefing Documents Paediatric plans/applications Investigator Brochures IMPDs Marketing Authorisation Applications New Drug Applications Biologic License Applications DMFs according to area of expertise.
- Lead multijurisdiction 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.
- Ensure delivery of project goals within agreed timelines maintaining oversight of project budgets.
- Lead meetings with internal and external stakeholders on matters related to any current and/or future projects contracts or new business opportunities.
- Support Scendeas Business Development in sales/marketing introductions and generate additional business from current clients.
- Line manage train and mentor members of the Scendea Operational team including providing technical leadership.
Skills and Experience
- A high scientific calibre with a relevant science focused BSc (or equivalent) and a higher degree in a biomedical field or equivalent (e.g. a life/physical science focused MSc or preferably a PhD).
- A minimum of ten years of drug development experience.
- A minimum of ten years of regulatory experience working with either FDA MHRA and/or EMA submissions including meetings/negotiation. Regulatory experience may include time within a National Competent Authority.
- Demonstrated experience with a broad range of products including recombinant proteins and peptides (including antibodies) prophylactic and therapeutic vaccines biosimilar products advanced therapy medicinal products (tissue cell and gene therapy) RNA or DNA based products live biotherapeutics and small molecule NCE and/or generic chemical entities.
- Direct experience preferred in providing strategic regulatory planning from earlystage 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.
- Exemplary organisational and time management skills with a high level of attention to detail and the proven ability to work both proactively and autonomously.
- High level of verbal communication and presentation skills in English computer literacy and competency in MS Office programs.
- Willingness to work flexible hours and travel for short periods sometimes at short notice within the country of employment or internationally.
Benefits
Benefits Package
- A competitive salary.
- Generous bonus program which rewards success.
- 26 days holiday plus discretionary additional days for birthday and work anniversary and public holidays.
- 5% employer pension contribution.
- Private Healthcare insurance.
- Access to Employee Assistance Programme.
- Employee Ownership Trust Scheme.
- A challenging and stimulating position for a dynamic and competent scientist looking to contribute to a growing business and a rapidly expanding team.
- Coaching mentoring and support of your continuous learning and professional development within a highly recognised international team.
The Company
Scendea is an international product development and regulatory consulting group delivering marketleading scientific expertise & regulatory solutions to advance healthcare innovation worldwide. We are passionate about delivering strategic and operational support to clients with a strong commitment to problemsolving and redefining customer service. Our goal is to streamline the product development process reduce timetomarket and minimise overall development costs.
With a current team of over 50 staff based in the UK Netherlands Australia and the US Scendea is undergoing a period of significant growth with the addition of new office locations and service lines to facilitate the delivery of expert and strategic global regulatory consulting services to our rapidly growing client base. We are equally committed to making a positive impact on society by managing our environmental impacts and contributing to a lowcarbon economy. Our inclusive work culture values transparency ethical collaboration with clients and employee involvement in key decisionmaking processes ensuring that our team is respected supported and engaged.
As a Scendea Employee
Part of what makes Scendea successful is the highly motivated people who work for us and their enthusiasm for what we do and stand for. We recruit individuals whose passion drive integrity and customer orientation shines through. You are a motivated individual who can instil trust and confidence in our customer relationships whilst having a natural aptitude for getting the best out of people internally. You will inspire others through your commitment motivation expertise professional manner and always placing the customer at the centre of everything you do.
Eligibility & Conditions
Applicants must reside and be eligible to work in the UK without the requirement for sponsorship now or in the future. Closing date for applications is Monday 3rd February 2025 and candidates will be notified by of the outcome of their application no later than Friday 7th February 2025.
Employment Type
Full Time
