At a Glance
- Tasks: Provide strategic regulatory advice and lead clinical development projects for innovative medicinal products.
- Company: Join Scendea, a global leader in product development and regulatory consulting.
- Benefits: Flexible working options, competitive salary, and opportunities for professional growth.
- Other info: Dynamic team environment with opportunities for mentorship and leadership.
- Why this job: Make a real impact in the healthcare industry while advancing your career.
- Qualifications: Relevant science degree and significant experience in drug development and regulatory submissions.
The predicted salary is between 60000 - 80000 £ per year.
The Role Scendea is seeking a highly motivated individual to join our global team as a full-time Consultant/Senior Consultant (Clinical).
This position is affiliated to our Bishop's Stortford, UK Office, with some opportunity to work remotely.
The ideal candidate will have established experience in working independently on a range of clinical development topics in compliance with current regulatory requirements.
They will need to be competent in direct hands-on clinical writing and review of documents for regulatory submissions.
This is an excellent opportunity to progress your career at a rapidly growing product development, regulatory, and compliance consultant 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 strategies for clients.
Role Requirements Provide strategic, technical and regulatory advice/services to clients with a special interest in Clinical 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 Clinical 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 Ph D).
A minimum of two years (Consultant) and a minimum of 5 years (Senior Consultant) of employment-related experience in drug development.
A minimum of two years (Consultant) and a minimum of 5 years (Senior Consultant) of regulatory experience, working with either TGA, FDA, EMA, and/or MHRA submissions.
Experience in project management and proven ability to balance competing priorities and complete work within a set timeframe.
Demonstrated clinical development experience across a range of therapeutic indications/disease areas.
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.
The Company Scendea is an international product development, regulatory, and compliance consulting group delivering market-leading scientific expertise
Senior Regulatory Consultant (Clinical) employer: Scendea
Scendea is an exceptional employer that fosters a collaborative and innovative work culture, providing employees with the opportunity to grow their careers in the dynamic field of regulatory consulting. Located in Bishop's Stortford, UK, our team enjoys a blend of in-office collaboration and remote flexibility, along with comprehensive training and mentorship programs that empower staff to excel in their roles. Join us to make a meaningful impact in clinical development while benefiting from a supportive environment that values professional growth and high-quality client service.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Consultant (Clinical)
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Scendea looking for candidates who are engaged and informed.
We think you need these skills to ace Senior Regulatory Consultant (Clinical)
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Scendea. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Scendea
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Scendea’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
