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- Tasks: Manage regulatory submissions and coordinate projects in the life sciences sector.
- Company: Join Parexel, a leader in regulatory affairs with a dynamic team culture.
- Benefits: Flexible work options, professional growth opportunities, and a collaborative environment.
- Why this job: Make a real impact in the life sciences industry while developing your expertise.
- Qualifications: Degree in life sciences and some regulatory experience preferred.
- Other info: Exciting career growth potential in a supportive team setting.
The predicted salary is between 36000 - 60000 £ per year.
When our values align, there's no limit to what we can achieve. Are you passionate about regulatory affairs in the life science industry? Do you thrive in a dynamic team environment and enjoy managing complex projects? Parexel is seeking a talented Senior Regulatory Affairs Associate with biologics or vaccines background to join our growing team!
As a Senior Regulatory Affairs Associate CMC at Parexel, you will be at the forefront of managing and coordinating regulatory submissions across various markets. This role offers an excellent opportunity to develop your expertise in regulatory affairs while working with a diverse range of clients and stakeholders. The role can be home or office based in various European locations.
Role Responsibilities- Manage lifecycle maintenance activities, including renewals, variations, and responses to deficiency letters
- Coordinate submission and management work in Veeva Vault
- Collaborate with various stakeholders, attending regular calls and meetings
- May serve as Project Lead for small-scale projects or Work Stream Lead on larger projects
- Ensure project team delivers high-quality work meeting client expectations and timelines
- Manage project financials and identify new business opportunities
- Deliver consulting services within your area of expertise
- Maintain professional interactions with clients and internal teams
- University degree in a life science discipline
- Initial years of regulatory experience in EU and other non-EU markets preferred
- Proficiency in Module 1 and 3 writing with biologics and/or vaccines
- Strong organizational and prioritization skills
- Excellent communication and teamwork abilities
- Ability to work independently and under guidance of Project Leads or Technical SMEs
- Commitment to continuous learning and self-development
- Fluent in English, written and spoken
Senior Regulatory Affairs Associate - CMC biologics or vaccines in Uxbridge employer: Parexel
Contact Detail:
Parexel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate - CMC biologics or vaccines in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those with experience in biologics or vaccines. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory submissions and lifecycle maintenance activities. Be ready to discuss your experience with Veeva Vault and how you've managed complex projects in the past.
✨Tip Number 3
Showcase your teamwork skills! During interviews, highlight examples of how you've collaborated with stakeholders and led project teams. This will demonstrate your ability to thrive in a dynamic team environment.
✨Tip Number 4
Don't forget to apply through our website! We love seeing candidates who are genuinely interested in joining our team. Tailor your application to reflect your passion for regulatory affairs and your commitment to continuous learning.
We think you need these skills to ace Senior Regulatory Affairs Associate - CMC biologics or vaccines in Uxbridge
Some tips for your application 🫡
Show Your Passion: Let us see your enthusiasm for regulatory affairs in the life sciences! In your application, share why you’re excited about this field and how your background aligns with our mission at Parexel.
Tailor Your CV: Make sure your CV highlights your experience with biologics or vaccines. We want to see how your skills match the role, so don’t be shy about showcasing relevant projects and achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain how you can manage complex projects and collaborate with diverse teams. Keep it engaging and personal – we love getting to know our candidates!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Parexel
✨Know Your Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in biologics and vaccines. Familiarise yourself with Module 1 and 3 writing, as well as the lifecycle maintenance activities mentioned in the job description. This will show that you're not just interested in the role but also have a solid understanding of what it entails.
✨Showcase Your Team Spirit
Since collaboration is key in this role, be ready to share examples of how you've successfully worked in teams before. Highlight any experiences where you managed complex projects or coordinated with various stakeholders. This will demonstrate your ability to thrive in a dynamic team environment.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and how you handle project challenges. Think of specific instances where you had to manage project financials or respond to deficiency letters. Practising these scenarios will help you articulate your thought process clearly during the interview.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your genuine interest in the company and the role. Inquire about the types of projects you might lead or how the team collaborates on submissions. This not only shows your enthusiasm but also helps you gauge if the company culture aligns with your values.
