Consultant (CMC) US

Scendea • Washington, DC

6d • Hybrid

About The Position

Scendea is seeking a highly motivated individual to join our global team as a full -time Consultant (CMC). This is a hybrid position, affiliated to our Washington, D.C. Office, with a requirement to work in the office a minimum of three days per week. 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 high -quality regulatory technical advice and product development

Requirements

• A high scientific calibre with a life science -focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science -focused MSc or preferably a PhD).
• A minimum of two years of drug development experience
• A minimum of two years of experience in regulatory with either FDA, MHRA, and/or EMA.
• Experience in project management and proven ability to balance competing priorities and complete work within a set timeframe.
• Ability and willingness to lead a small team and deliver internal mentorship, education and training in chosen field.
• 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.

Responsibilities

• Provide strategic, technical and regulatory advice/services to clients with a special interest in Chemistry, Manufacturing, and Controls (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, Pre -INDs, 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 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.
• 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 Scendea's 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree