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- Tasks: Lead regulatory submissions and ensure compliance with EMA and MHRA requirements.
- Company: Join a well-established consultancy in the growing pharmaceutical industry.
- Benefits: Be part of a dynamic team with opportunities for professional growth and innovation.
- Why this job: Make a real impact in drug safety and licensing while developing your career.
- Qualifications: Requires 5+ years in regulatory affairs and a degree in Life Sciences or related field.
- Other info: Work independently and collaboratively in a fast-paced environment.
The predicted salary is between 43200 - 72000 £ per year.
Job Description Due to continued expansion we are currently seeking an additional Senior Regulatory Affairs Executive to join our team in a well-established Consultancy. You would have proven success in your current role and an ambition to continually develop together with commercial awareness, a drive to innovate and be a key part of a growing company in the pharmaceutical space. This position requires a minimum of five years experience working in pharmaceutical regulatory affairs with knowledge of the drug development process, eCTD Dossier preparation, submissions management, and other regulatory functions. You will have the ability to work independently with minimal supervision as well as in a team and have an eye for detail with respect to documentation. The position involves supporting the activities within the Regulatory areas of the company including drug safety and licensing of medicines. You will have a degree in Life Sciences, Chemistry, Applied Biology or Pharmacy, excellent communication and negotiation skills, together with the ability to work independently. Key Duties and Responsibilities Lead the preparation and submission of regulatory submissions, including marketing authorization applications, variations, and lifecycle management activities, ensuring alignment with EMA and MHRA requirements. Preparation of regulatory submissions for medicinal products, which may inc…
Senior Regulatory Affairs Executive employer: ProductLife Group
Contact Detail:
ProductLife Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Executive
✨Tip Number 1
Make sure to stay updated on the latest regulations and guidelines from EMA and MHRA. This knowledge will not only help you in your role but also demonstrate your commitment to the field during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical regulatory affairs space. Attend industry conferences or webinars to connect with others and learn about potential job openings that may not be advertised.
✨Tip Number 3
Highlight your experience with eCTD Dossier preparation and submissions management in conversations. Being able to discuss specific projects or challenges you've faced can set you apart from other candidates.
✨Tip Number 4
Demonstrate your ability to work independently and as part of a team by sharing examples from your past roles. This will show that you can adapt to different working styles and contribute effectively to our growing company.
We think you need these skills to ace Senior Regulatory Affairs Executive
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Senior Regulatory Affairs Executive position. Highlight your relevant experience in pharmaceutical regulatory affairs and your knowledge of the drug development process.
Tailor Your CV: Customize your CV to emphasize your five years of experience in regulatory affairs, focusing on your achievements in eCTD Dossier preparation and submissions management. Use specific examples that demonstrate your ability to work independently and as part of a team.
Craft a Compelling Cover Letter: Write a cover letter that showcases your ambition to develop within the pharmaceutical space. Discuss your commercial awareness and drive to innovate, and explain how these qualities make you a great fit for the company.
Highlight Communication Skills: In both your CV and cover letter, emphasize your excellent communication and negotiation skills. Provide examples of how you've successfully led regulatory submissions and collaborated with teams to achieve compliance with EMA and MHRA requirements.
How to prepare for a job interview at ProductLife Group
✨Showcase Your Experience
Be prepared to discuss your previous roles in regulatory affairs, especially focusing on your experience with eCTD Dossier preparation and submissions management. Highlight specific examples where you successfully led regulatory submissions or navigated complex regulatory environments.
✨Demonstrate Commercial Awareness
Understand the current trends in the pharmaceutical industry and be ready to discuss how they impact regulatory affairs. Showing that you are aware of market dynamics and can align regulatory strategies with business goals will impress the interviewers.
✨Highlight Team Collaboration
While the role requires independence, emphasize your ability to work effectively within a team. Share examples of how you have collaborated with cross-functional teams to achieve regulatory objectives, ensuring that you convey your communication and negotiation skills.
✨Prepare for Technical Questions
Expect technical questions related to drug development processes and regulatory requirements. Brush up on your knowledge of EMA and MHRA guidelines, and be ready to discuss how you would approach specific regulatory challenges in the pharmaceutical space.
