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- Tasks: Lead global regulatory strategies and manage licensing activities for pharmaceutical products.
- Company: Join a top-tier pharmaceutical company making waves in the industry.
- Benefits: Enjoy a competitive salary, remote work options, and a comprehensive benefits package.
- Why this job: Be the face of regulatory affairs and impact global health with innovative products.
- Qualifications: PhD preferred; experience in regulatory frameworks and drug development is essential.
- Other info: This is a senior role with significant responsibility and influence in the organisation.
The predicted salary is between 54000 - 84000 £ per year.
Job Type: Full-time permanent position
Location: UK or Europe – Hybrid/remote-based role
Attractive salary plus benefits package
Working for one of the industry’s leading pharmaceutical companies, this is a fantastic opportunity to provide expert regulatory knowledge from pre-clinical through clinical studies to initial registration in key global markets. You will be ‘the face’ of the Global Regulatory function on cross-functional global project teams for new product introductions and single point of accountability for Global Regulatory Strategy Leadership and policy development.
You will sit within the Pharmaceutical Diagnostics; however, you will only be managing the molecule as opposed to the device. The business has assets ranging from pre-clinical through to late stage, and you will be responsible for all regulatory activities related to your assigned assets.
- Lead all licensing/filling activities assigned to the development portfolio.
- Drive global Regulatory Affairs strategies for the portfolio, including managing internal and external stakeholders.
- Lead interactions with the health authorities/local agencies – MHRA, EMA & FDA, including pre-submission meetings, pre-IND meetings, Scientific advice, and type B/C meetings with the FDA.
- Support both early and late-stage development activities CTAs, IND, ODD, PIPS, IND, IMPD, and initial MAAs.
- Support and lead cross-functional team discussions with medical, quality, PV, and other departments.
- Fulfilment of regulatory compliance obligations.
- Support assets from pre-clinical, phase 1, 2, and 3.
A PhD qualified profile is desirable but not a must. Knowledge of regulatory frameworks and external environments as it applies to project-specific global regulatory strategy document (GRSD) delivery. Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs. This role is a very senior role within the regulatory team, and the business is looking for a wealth of experience across the drug development cycle.
Scientific Team Lead/Scientific Director - remote employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Scientific Team Lead/Scientific Director - remote
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who have experience in regulatory affairs. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends in global regulatory strategies.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks of the MHRA, EMA, and FDA. Understanding their processes and requirements will not only boost your confidence but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences leading cross-functional teams and managing stakeholders. Highlight specific examples where you successfully navigated complex regulatory challenges, as this will showcase your leadership skills and strategic thinking.
✨Tip Number 4
Stay updated on the latest developments in drug regulations and compliance obligations. Subscribing to industry newsletters or joining professional associations can provide valuable insights that you can bring up in conversations with the hiring team.
We think you need these skills to ace Scientific Team Lead/Scientific Director - remote
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in the pharmaceutical industry. Emphasise your knowledge of regulatory frameworks and any leadership roles you've held.
Craft a Compelling Cover Letter: In your cover letter, explain why you are the perfect fit for the role. Discuss your experience with global regulatory strategies and your ability to manage cross-functional teams effectively.
Showcase Relevant Achievements: Include specific examples of past successes in regulatory affairs, such as successful submissions or interactions with health authorities. Quantify your achievements where possible to demonstrate your impact.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Cpl Life Sciences
✨Showcase Your Regulatory Expertise
Make sure to highlight your knowledge of regulatory frameworks and your experience with health authorities like the MHRA, EMA, and FDA. Be prepared to discuss specific examples where you've successfully navigated complex regulatory environments.
✨Demonstrate Leadership Skills
As this is a senior role, it's crucial to showcase your leadership abilities. Share experiences where you've led cross-functional teams or driven regulatory strategies that resulted in successful product submissions.
✨Prepare for Technical Questions
Expect technical questions related to pre-clinical and clinical study regulations. Brush up on your knowledge of CTAs, INDs, and MAAs, and be ready to explain how you would approach these processes in your new role.
✨Engage with Stakeholders
Since managing internal and external stakeholders is key, prepare to discuss how you've effectively communicated and collaborated with various departments. Highlight any strategies you've used to ensure alignment and compliance across teams.
