At a Glance
- Tasks: Conduct strategic regulatory activities for products and markets to obtain Marketing Authorizations.
- Company: Pfizer, a patient-centric company dedicated to transforming lives.
- Benefits: Hybrid work model, flexible culture, and commitment to diversity.
- Other info: Opportunities for personal development and career growth.
- Why this job: Join us in making breakthroughs that change patients' lives.
- Qualifications: Life sciences or chemistry degree; experience in Regulatory Affairs preferred.
The predicted salary is between 40000 - 50000 € per year.
JOB SUMMARY
Under the supervision of line management or guidance from an experienced Senior Regulatory Manager, conduct agreed strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.
JOB RESPONSIBILITIES
- Deliver Regulatory Strategy and Advise Cross-Functional Teams
- Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
- Manage New Registration/Marketing Authorization Applications
- Manage Marketing Authorization (MA) Variation Applications
- Manage MA Renewal Applications
- Management of NRA queries
- Develop knowledge of NRA’s expectations, ways of working etc. to inform assigned product regulatory strategies. Share updates and regulatory intelligence with colleagues.
- Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.
- Respond to spontaneous requests from authorities promptly and accurately.
- Support the strategic clinical development activities in partnership with national Regulatory Authorities, Above Country Regulatory Strategists and Clinical Trials Regulatory Strategy Execution (CTRSE) as applicable.
- Populate and Maintain Regulatory Databases
- Obtain NRA Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)
- Safeguard Compliance in the Management of Packaging and Prescribing Information Component updates
- Support MA Divestments, MA Cancellations, product Discontinuations and Supply Continuity
- Support Third Party Licenses
- Support regulatory activities for the development and maintenance of medical devices if required.
- Contribute to Good Regulatory Practice (GRP)
- Support Regulatory Group Development
- Lead Personal Development
QUALIFICATIONS / SKILLS
- Life sciences or chemistry graduate to honours level or equivalent
- Master’s degree, Post Graduate Diploma or PhD preferred
- Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory)
- Previous experience and proven track record in Regulatory (Human Medicinal Products)
- Computer literacy
- Excellent written and verbal communication skills
- Proven strength in analytical thinking
Work Location Assignment: Hybrid (some office presence is required)
Senior Regulatory Associate in Banstead employer: Pfizer
Pfizer is an exceptional employer, offering a dynamic and inclusive work culture that prioritises employee well-being and professional growth. With a commitment to flexibility and a focus on breakthrough innovations in healthcare, employees are empowered to make meaningful contributions while enjoying a supportive environment that values diversity and collaboration. Located in Walton Oaks, the hybrid work model allows for a balanced approach to work-life harmony, making it an ideal place for those seeking a rewarding career in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Associate in Banstead
✨Tip Number 1
Network like a pro! Reach out to current employees at Pfizer or in the regulatory field on LinkedIn. A friendly chat can give you insider info and might just get your foot in the door.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of regulatory strategies and recent changes in legislation. Show us you’re not just a candidate, but a passionate expert ready to make an impact!
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. We want to hear about your past experiences and how they’ve shaped you into the perfect fit for our team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our mission to change lives.
We think you need these skills to ace Senior Regulatory Associate in Banstead
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Senior Regulatory Associate role. Highlight your relevant experience in regulatory affairs and how it aligns with our mission at StudySmarter.
Showcase Your Skills:Don’t forget to emphasise your analytical thinking and communication skills. These are key for the role, so give examples of how you've used them in past experiences.
Be Clear and Concise:When writing your application, keep it clear and to the point. We appreciate straightforwardness, so avoid jargon and make your qualifications easy to understand.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets seen by the right people at StudySmarter!
How to prepare for a job interview at Pfizer
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to the role. Familiarise yourself with the specific regulatory frameworks that apply to the products you'll be working with, as well as any recent changes in legislation. This will show your interviewers that you're proactive and knowledgeable.
✨Prepare for Scenario Questions
Expect to be asked how you would handle specific regulatory challenges or scenarios. Think of examples from your past experience where you've successfully navigated complex regulatory issues. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly and effectively.
✨Showcase Your Communication Skills
As a Senior Regulatory Associate, you'll need to communicate complex information clearly. Prepare to demonstrate your written and verbal communication skills during the interview. You might be asked to explain a regulatory concept or provide advice on a hypothetical situation, so practice articulating your thoughts concisely.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company's approach to regulatory strategy or how they support their teams in staying updated with regulatory changes. This not only shows your interest in the role but also helps you gauge if the company aligns with your career goals.
