Senior Consultant (CMC) UK

The Role

Scendea is seeking a highly motivated individual to join our
global team as a full -time Senior Consultant (CMC). This
is a hybrid position, affiliated to our UK Bishop's 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 product development, regulatory, and compliance consulting group. 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

Role Requirements

• 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.
  
  

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 5 years drug development experience.
  
• A
  minimum of 5 years regulatory experience, working with either the FDA,
  MHRA, and/or EMA submissions, including meetings/negotiation. Regulatory
  experience may include time within a National Competent Authority.
  
• Authoring of CMC sections of regulatory documentation is required. MAA/BLA Experience is highly desirable. 
  
• 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 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.
  
• 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 market -leading 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 problem -solving and redefining customer service. Our goal
is to streamline the product development process, reduce time -to -market, 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 low -carbon economy. Our inclusive work culture values transparency,
ethical collaboration with clients, and employee involvement in key
decision -making 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.