Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Manage regulatory submissions and collaborate with diverse teams on exciting projects.
- Company: Join Parexel, a leader in life sciences with a dynamic team culture.
- Benefits: Flexible work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in regulatory affairs while working with innovative plasma products.
- Qualifications: Degree in life sciences and some regulatory experience preferred.
- Other info: Great chance to develop your skills in a supportive environment.
The predicted salary is between 36000 - 60000 £ per year.
Overview
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 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
Skills and experience
- 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 for plasma products
- 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
#J-18808-Ljbffr
Senior Regulatory Affairs Associate CMC (plasma products) employer: Parexel
Contact Detail:
Parexel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate CMC (plasma products)
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory submissions and lifecycle maintenance activities. We recommend practising common interview questions with a friend to boost your confidence!
✨Tip Number 3
Showcase your project management skills! Be ready to discuss specific examples of how you’ve managed complex projects or collaborated with stakeholders. We love hearing about real-life experiences that demonstrate your expertise.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who are eager to make an impact in the life sciences industry.
We think you need these skills to ace Senior Regulatory Affairs Associate CMC (plasma products)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Associate role. Highlight your relevant experience in regulatory affairs, especially with plasma products, and showcase your skills in managing complex projects.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you a perfect fit for our team at Parexel. Don't forget to mention your experience with Veeva Vault!
Showcase Your Team Spirit: We love collaboration at Parexel! In your application, emphasise your teamwork abilities and any experiences where you've successfully worked with diverse stakeholders. This will show us that you can thrive in our dynamic environment.
Apply Through Our Website: To make sure your application gets the attention it deserves, apply directly through our website. It’s the best way for us to see your enthusiasm and ensure you’re considered for this exciting opportunity!
How to prepare for a job interview at Parexel
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in the life sciences sector. Familiarise yourself with Module 1 and 3 writing for plasma products, as this will likely come up during your interview.
✨Showcase Your Project Management Skills
Be ready to discuss your experience managing complex projects. Think of specific examples where you've coordinated submissions or worked with stakeholders, and be prepared to explain how you ensured high-quality outcomes.
✨Demonstrate Team Spirit
Since collaboration is key in this role, highlight your teamwork abilities. Share instances where you've successfully worked with diverse teams or led small-scale projects, showcasing your communication skills and ability to maintain professional interactions.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s approach to regulatory affairs and their expectations for the role. This shows your genuine interest and helps you assess if the company culture aligns with your values.
