At a Glance
- Tasks: Conduct strategic regulatory activities for products and markets to secure Marketing Authorizations.
- Company: Join Pfizer, a leader in healthcare innovation with a commitment to diversity.
- Benefits: Enjoy health insurance, retirement plans, generous leave policies, and wellness programs.
- Other info: Hybrid work environment with opportunities for personal and professional growth.
- Why this job: Make a real impact in healthcare while developing your regulatory expertise.
- Qualifications: Life sciences or chemistry degree; experience in regulatory for human medicinal products preferred.
The predicted salary is between 46000 - 52000 € 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
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)
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Confident Employer
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Benefits at Pfizer
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, holiday time and sick time are just the beginning, with a 12 week parental leave policy for both parents of a newborn, 10 day caregiver leave for those times when your family needs you, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
Senior Regulatory Associate in London employer: Pfizer, S.A. de C.V
Pfizer is an exceptional employer that prioritises the well-being and professional growth of its employees, offering a hybrid work environment that fosters collaboration and innovation. With comprehensive health and wellness benefits, generous parental leave, and a commitment to diversity and inclusion, Pfizer empowers its workforce to thrive both personally and professionally. Join us in a culture that values your unique contributions and supports your journey towards meaningful impact in the healthcare sector.
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 current employees at Pfizer or in the regulatory field on LinkedIn. A friendly chat can give you insider info and might just lead to a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory strategies and recent changes in legislation. We want to see that you're not just qualified, but genuinely passionate about the field!
✨Tip Number 3
Showcase your analytical skills during interviews. Be ready to discuss how you've tackled complex regulatory challenges in the past. We love candidates who can think critically and adapt!
✨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 activities and how it aligns with our business goals. We want to see how you can contribute to our team!
Showcase Your Skills:Don’t forget to emphasise your analytical thinking and communication skills. These are key for this position, so give us examples of how you've used these skills in past roles. We love seeing real-life applications!
Be Clear and Concise:When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon unless it's necessary. We appreciate a well-structured application that’s easy to read!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets to the right people. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at Pfizer, S.A. de C.V
✨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 potential employer that you're proactive and knowledgeable.
✨Prepare for Scenario Questions
Expect to be asked about 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.
✨Show Your Team Spirit
This role involves a lot of cross-functional collaboration, so be ready to discuss how you work with others. Share examples of how you've provided regulatory advice to different teams and how you’ve managed to keep everyone aligned on compliance goals. Highlight your communication skills and ability to build relationships.
✨Ask Smart Questions
At the end of the interview, don’t forget to ask insightful questions. Inquire about the company’s approach to regulatory strategy or how they support their employees' professional development in this area. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
