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- Tasks: Lead regulatory strategies for innovative medicines and ensure compliance with European regulations.
- Company: Join a global pharmaceutical company dedicated to improving patient access to innovative treatments.
- Benefits: Enjoy a flexible work schedule with three days in the office and competitive perks.
- Why this job: Make a real impact in healthcare while working in a dynamic, supportive environment.
- Qualifications: Experience in Regulatory Affairs and strong knowledge of European regulatory requirements 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.
Compliance Senior Manager - Contract employer: Pro4orm People Ltd
Contact Detail:
Pro4orm People Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Compliance Senior Manager - Contract
✨Tip Number 1
Familiarise yourself with the latest European regulatory requirements and guidelines. This will not only help you understand the role better but also allow you to speak confidently about how your experience aligns with the company's needs during any discussions.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in the pharmaceutical industry. Engaging with them can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss specific examples of how you've influenced regulatory strategies in past roles. Highlighting your problem-solving skills and adaptability will demonstrate your capability to handle the challenges of this position.
✨Tip Number 4
Showcase your proficiency with relevant software and databases like eCTD publishing and validation. Being able to discuss your hands-on experience with these tools will set you apart from other candidates.
We think you need these skills to ace Compliance Senior Manager - Contract
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the key responsibilities and required skills. Highlight your experience with European regulatory requirements and any relevant projects you've worked on.
Tailor Your CV: Customise your CV to reflect the specific skills mentioned in the job description, such as influencing, problem-solving, and project management. Use clear examples that demonstrate your expertise in regulatory affairs.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the role. Emphasise your understanding of European regulatory frameworks and how your previous experiences align with the company's goals for innovative medicines.
Proofread and Edit: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your application is professional and polished, reflecting your attention to detail.
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 expectations.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled challenges in previous roles, especially those related to regulatory affairs. Highlight your ability to critically evaluate data and pre-empt deficiencies.
✨Demonstrate Teamwork and Communication
Since this role requires effective inter-cultural communication, think of instances where you've successfully collaborated with diverse teams. Be ready to discuss how you adapt your communication style to different audiences.
✨Familiarise Yourself with Relevant Tools
Get comfortable with Microsoft Office software and databases mentioned in the job description. If you have experience with eCTD publishing or the MHRA portal, be prepared to share specific examples of how you've used these tools.
