At a Glance
- Tasks: Conduct strategic regulatory activities for products and markets to obtain Marketing Authorizations.
- Company: Join Pfizer, a leader in transforming healthcare with a patient-centric approach.
- Benefits: Hybrid work model, competitive salary, and a culture of flexibility and support.
- Other info: Diverse and inclusive workplace with excellent career development opportunities.
- Why this job: Make a real impact on patients' lives through innovative regulatory strategies.
- Qualifications: Life sciences or chemistry degree; experience in Regulatory Affairs preferred.
The predicted salary is between 40000 - 50000 € per year.
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
- 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 London employer: Pfizer
Pfizer is an exceptional employer, offering a dynamic and inclusive work environment in Walton Oaks, where employees are empowered to drive meaningful change in healthcare. With a strong focus on personal development, flexibility, and a commitment to diversity, Pfizer fosters a culture that encourages innovation and collaboration, making it an ideal place for professionals seeking to make a significant impact in the regulatory field.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Associate in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company’s recent projects and regulatory challenges. Show them you’re not just another candidate; you’re genuinely interested in their work and ready to contribute.
✨Tip Number 3
Practice your answers to common regulatory interview questions. We all know the basics, but being able to articulate your experience and how it aligns with their needs can set you apart.
✨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 team.
We think you need these skills to ace Senior Regulatory Associate in London
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 the responsibilities mentioned in the job description.
Showcase Your Skills:Don’t forget to emphasise your analytical thinking and communication skills. These are key for this position, so provide examples of how you've used these skills in previous roles or projects.
Be Clear and Concise:When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon unless it's relevant to the role. We want to see your qualifications without having to sift through unnecessary fluff!
Apply Through Our Website:We encourage you to apply directly through our website. This ensures your application gets to the right people quickly and helps us keep track of all applicants efficiently. Plus, it’s super easy!
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 not just knowledgeable but also proactive about staying updated.
✨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 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. Practice explaining regulatory concepts in simple terms, as if you were talking to someone without a regulatory background. This will demonstrate your ability to collaborate with cross-functional teams and stakeholders.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready to ask your interviewers. Inquire about the company's approach to regulatory strategy or how they support professional development within the regulatory team. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
