At a Glance
- Tasks: Lead European regulatory filings and manage operational aspects of submissions.
- Company: Join a global pharmaceutical company making a difference in healthcare.
- Benefits: Full-time role with a 12-month contract, working 35 hours a week.
- Why this job: Be at the forefront of regulatory affairs, collaborating with diverse teams and stakeholders.
- Qualifications: PhD preferred with strong experience in EU regulatory procedures and project leadership.
- Other info: Equal Opportunities Employer committed to diversity and inclusion.
The predicted salary is between 36000 - 60000 £ per year.
Our client, a global pharmaceutical company is currently looking for a EU Regulatory Affairs Specialist to join their team based on the outskirts of London on a full time, 12-month temporary basis (35 hours per week).
In this role, you’ll lead and manage the operational aspects of European regulatory filings, collaborating closely with European Regulatory groups and a range of regional and global stakeholders.
Key Responsibilities
- Oversee the preparation and filling of Marketing Authorisation Applications (MAA) and Life Cycle Management for European Centralised Procedures, ensuring smooth regulatory submissions
- Coordinate and communicate submission timelines, updates and regulatory changes, keeping all stakeholders well-informed
- Support logistics for key meetings with the EMA and national Health Authorities, collaborating closely with cross-functional teams to drive strategy
- Author and review regulatory documents, staying current on industry guidelines and participating in global taskforces
Requirements
- Advanced scientific background (PhD preferred) with strong experience in European regulatory procedures
- Proven project leadership skills, with expertise in handling MAA processes and supporting strategic initiatives
- Strong communication and collaboration skills, with a deep understanding of EU regulatory requirements and the ability to connect effectively across teams
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.
EU Regulatory Affairs Specialist employer: Park Street People
Contact Detail:
Park Street People Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land EU Regulatory Affairs Specialist
✨Tip Number 1
Familiarize yourself with the latest EU regulatory guidelines and procedures. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a fast-paced environment.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who work in regulatory affairs. Attend relevant conferences or webinars to make connections that could lead to valuable insights and potential referrals.
✨Tip Number 3
Prepare to discuss specific examples of your project leadership experience, particularly related to MAA processes. Highlight how you've successfully managed timelines and collaborated with cross-functional teams in past roles.
✨Tip Number 4
Showcase your communication skills by practicing how you would explain complex regulatory concepts to non-experts. This will be crucial in demonstrating your ability to connect effectively across teams during the interview.
We think you need these skills to ace EU Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and requirements. Tailor your application to highlight your relevant experience in European regulatory affairs and project leadership.
Highlight Relevant Experience: In your CV and cover letter, emphasize your advanced scientific background and any specific experience you have with Marketing Authorisation Applications (MAA) and European regulatory procedures. Use concrete examples to demonstrate your expertise.
Showcase Communication Skills: Since strong communication and collaboration skills are essential for this role, provide examples of how you've effectively communicated with stakeholders or led cross-functional teams in your previous positions.
Proofread Your Application: Before submitting your application, carefully proofread your documents to ensure there are no errors. A well-written application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Park Street People
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of European regulatory procedures during the interview. Be prepared to discuss specific experiences with Marketing Authorisation Applications (MAA) and how you've navigated the complexities of regulatory submissions.
✨Demonstrate Project Leadership Skills
Since project leadership is crucial for this role, come equipped with examples of past projects where you led a team or initiative. Discuss how you coordinated timelines and managed stakeholder communications effectively.
✨Prepare for Technical Questions
Expect technical questions related to EU regulatory requirements and processes. Brush up on current industry guidelines and be ready to explain how you stay informed about changes in regulations.
✨Emphasize Collaboration Experience
This role requires strong collaboration skills. Share examples of how you've worked with cross-functional teams or engaged with external stakeholders like the EMA or national Health Authorities to drive strategic initiatives.