At a Glance
- Tasks: Provide regulatory guidance and innovative strategies for medicinal product development.
- Company: Scendea delivers expert regulatory solutions to advance global healthcare innovation.
- Benefits: Enjoy a competitive salary, bonuses, private healthcare, and generous holiday allowances.
- Other info: Opportunities for continuous learning and professional development in a growing international team.
- Why this job: Join a passionate team committed to problem-solving and making a positive societal impact.
- Qualifications: Requires a life science degree, 8 years of drug development experience, and regulatory expertise.
The predicted salary is between 36000 - 60000 € per year.
Are you looking to advance your career in regulatory affairs?
At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our biotech and pharmaceutical clients. If you are experienced in regulatory affairs and passionate about providing strategic and technical solutions to complex product development challenges, we’d love to hear from you.
What’s involved?
You will play a critical role in providing regulatory guidance and innovative strategies across a wide range of medicinal product development activities.
This includes:
- Providing innovative drug development plans, data gap analyses and international regulatory strategies for complex products within the changing regulatory environment.
- Contributing to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, IMPDs, CSRs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, according to area of expertise.
- Representing clients in regulatory agency interactions and providing regulatory solutions to agency objections.
- Collaborating across jurisdictions and disciplines to deliver expert consulting services.
What we are looking for:
- 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 8 years of drug development experience.
- A minimum of experience with FDA, and/or MHRA/EMA, including negotiation. Regulatory experience may include time within a National Competent Authority.
- 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.
Why Scendea?
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.
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.
You will also receive;
- A competitive salary.
- Generous bonus program, which rewards success.
- Holiday plus public holidays, and discretionary additional days for birthday and work anniversary.
- Employer pension contribution.
- Provision of 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.
Register your interest today!
We are always looking for talented individuals to join our global team. If this sounds like the next step in your career, click “Apply” to register your interest.
Regulatory Affairs Specialists in London employer: Scendea
At Scendea, we pride ourselves on being an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration in the field of regulatory affairs. Our inclusive culture values transparency and ethical practices, while providing ample opportunities for professional growth through coaching and mentoring. With competitive salaries, generous bonuses, and a commitment to employee well-being, Scendea is dedicated to supporting our team as we advance healthcare innovation worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialists in London
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines from agencies like the FDA and EMA. Understanding current trends and changes in regulations will not only enhance your knowledge but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector. Attend industry conferences, webinars, or local meetups to connect with others in the field. This can lead to valuable insights and potential referrals that may help you land the job.
✨Tip Number 3
Prepare for potential interviews by practising responses to common regulatory scenarios. Be ready to discuss your experience with drug development processes and how you've navigated complex regulatory challenges in the past.
✨Tip Number 4
Showcase your problem-solving skills during discussions. Scendea values innovative solutions, so be prepared to share examples of how you've successfully tackled regulatory issues or contributed to strategic planning in previous roles.
We think you need these skills to ace Regulatory Affairs Specialists in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights relevant experience in regulatory affairs, particularly with FDA and EMA. Emphasise your drug development experience and any specific projects that align with the role at Scendea.
Craft a Compelling Cover Letter:Write a cover letter that showcases your passion for regulatory affairs and your understanding of the challenges in medicinal product development. Mention how your skills can contribute to Scendea's mission of advancing healthcare innovation.
Highlight Relevant Qualifications:Clearly state your educational background, especially if you have a higher degree in a biomedical field. Include any certifications or training that are pertinent to regulatory affairs.
Showcase Problem-Solving Skills:In your application, provide examples of how you've successfully navigated complex regulatory challenges in the past. This will demonstrate your ability to deliver creative solutions, which is crucial for the role.
How to prepare for a job interview at Scendea
✨Know Your Regulatory Landscape
Familiarise yourself with the latest regulations and guidelines from agencies like the FDA, MHRA, and EMA. Being able to discuss recent changes or challenges in regulatory affairs will demonstrate your expertise and commitment to the field.
✨Prepare for Technical Questions
Expect to answer technical questions related to drug development plans, clinical trial applications, and regulatory strategies. Brush up on your knowledge of these documents and be ready to provide examples from your past experience.
✨Showcase Your Problem-Solving Skills
Be prepared to discuss specific challenges you've faced in regulatory affairs and how you overcame them. Highlighting your ability to provide innovative solutions will resonate well with the interviewers.
✨Emphasise Collaboration Experience
Since the role involves working across jurisdictions and disciplines, share examples of successful collaborations you've had in the past. This will illustrate your ability to work effectively within a team and with clients.
