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- Tasks: Lead regulatory strategies for innovative medicines and ensure compliance with European regulations.
- Company: Join a global pharmaceutical leader dedicated to improving patient access to groundbreaking treatments.
- Benefits: Enjoy a flexible work schedule with three days in the office and opportunities for professional growth.
- Why this job: Make a real impact on healthcare by facilitating fast access to life-changing medicines.
- Qualifications: Experience in Regulatory Affairs and proficiency in Microsoft Office and relevant databases are essential.
- Other info: We celebrate diversity and encourage applications from all backgrounds.
The predicted salary is between 48000 - 72000 £ per year.
Pro4orm People Ltd have partnered with a global pharmaceutical company in the search of a Senior Regulatory Affairs Manager. We are looking to speak to people who have an excellent understanding and experience of European Regulatory requirements. This is a full time permanent position, based in Berkshire three days a week.
This role will provide strategic regulatory and scientific support on non‐clinical and clinical development plans with an objective of getting fast access of innovative medicines to patients in the most efficient way. Provide regulatory input into development programs, registration documentation based on relevant regulatory guidance and critical assessment of data available for generic and speciality products. Critically evaluate data and scientific rationale to identify gaps and pre‐empt deficiencies prior to critical document closure in preparation of submission documentation.
An excellent understanding of European regulatory requirements to set up regulatory strategies in support of development programs for specialty products with focus on EU and other highly regulated territories.
The following skills are essential for the role:
- Influencing
- Problem solving
- Time and project management
- Flexibility/adaptability
- Independence
- Team working
- Customer focus
- Effective inter‐cultural communication skills
Experience with Regulatory Affairs and Microsoft Office software and databases (e.g. eCTD publishing and validation, CESP, MHRA portal, Eudralink, Excel etc.)
We welcome applications from all qualified candidates regardless of race, gender, sexual orientation, religion, disability, or background.
Senior Regulatory Affairs Manager Contract employer: Pro4orm People Ltd
Contact Detail:
Pro4orm People Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Manager Contract
✨Tip Number 1
Familiarise yourself with the latest European regulatory guidelines and frameworks. This will not only help you understand the requirements better but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with specialty products. Engaging in discussions or attending relevant conferences can provide insights and potentially lead to referrals.
✨Tip Number 3
Showcase your problem-solving skills by preparing examples of how you've successfully navigated regulatory challenges in the past. Be ready to discuss these during interviews to highlight your practical experience.
✨Tip Number 4
Demonstrate your adaptability by being open to discussing various regulatory strategies for different types of products. This flexibility can set you apart as a candidate who is ready to tackle diverse challenges in the role.
We think you need these skills to ace Senior Regulatory Affairs Manager Contract
Some tips for your application 🫡
Understand the Role: Before you start writing your application, make sure you fully understand the responsibilities and requirements of the Senior Regulatory Affairs Manager position. Tailor your application to highlight your relevant experience in European regulatory requirements.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience with regulatory affairs, particularly in relation to non-clinical and clinical development plans. Use specific examples to demonstrate your understanding of regulatory strategies for specialty products.
Showcase Key Skills: Make sure to showcase essential skills mentioned in the job description, such as influencing, problem-solving, and effective inter-cultural communication. Provide concrete examples of how you've applied these skills in previous roles.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Pro4orm People Ltd
✨Know Your Regulatory Stuff
Make sure you have a solid grasp of European regulatory requirements. Brush up on the latest guidelines and be ready to discuss how your experience aligns with the role's needs.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled challenges in previous roles. Highlight your ability to critically evaluate data and pre-empt deficiencies, as this is crucial for the position.
✨Demonstrate Teamwork and Communication
Be ready to discuss how you've worked effectively in teams and communicated across cultures. This role requires strong inter-cultural communication skills, so share relevant experiences.
✨Familiarise Yourself with Relevant Tools
Since experience with Microsoft Office software and databases is essential, ensure you're comfortable discussing tools like eCTD publishing and validation. Mention any specific projects where you've used these tools.
