At a Glance
- Tasks: Conduct strategic regulatory activities for products and markets to secure Marketing Authorizations.
- Company: Dynamic life sciences company focused on innovation and compliance.
- Benefits: Hybrid work model, competitive salary, and opportunities for personal development.
- Other info: Collaborative environment with strong focus on career growth and regulatory best practices.
- Why this job: Join a team that shapes the future of healthcare through regulatory excellence.
- Qualifications: Life sciences or chemistry degree and experience in regulatory affairs required.
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
Qualifications / Skills
- Life sciences or chemistry graduate to honours level or equivalent
- Previous experience and proven track record in Regulatory (Human Medicinal Products)
- Excellent written and verbal communication skills
- Proven strength in analytical thinking
Work Location Assignment: Hybrid (some office presence is required)
Senior Regulatory Associate employer: Pfizer, S.A. de C.V
As a Senior Regulatory Associate, you will thrive in a dynamic and supportive work environment that prioritises employee growth and development. Our hybrid work model allows for flexibility while fostering collaboration with cross-functional teams, ensuring you have the resources and guidance needed to excel in your role. With a commitment to regulatory excellence and a culture that values innovation, we offer a rewarding career path where your contributions directly impact our mission to deliver safe and effective products to the market.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Associate
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that Senior Regulatory Associate role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory strategies and recent changes in legislation. We recommend practising common interview questions with a friend or mentor to boost your confidence and ensure you shine during the real deal.
✨Tip Number 3
Showcase your expertise! During interviews, share specific examples of how you've successfully managed marketing authorisations or navigated regulatory challenges. We want to see your analytical thinking in action!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Senior Regulatory Associate
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Senior Regulatory Associate role. Highlight your previous regulatory experience and any specific achievements that demonstrate your ability to manage Marketing Authorizations and Clinical Trial Applications.
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. Don’t forget to mention your understanding of NRA expectations and how you can contribute to our goals.
Showcase Your Communication Skills:Since excellent written communication is key in this role, ensure your application is clear, concise, and free of errors. Use professional language but keep it friendly – we want to see your personality shine through!
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, you’ll get to explore more about our company culture while you’re at it!
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 human medicinal products. Familiarise yourself with the specific requirements for Marketing Authorizations and Clinical Trial Applications, as this will show your potential employer that you're serious about the role.
✨Showcase Your Communication Skills
Since excellent written and verbal communication is key in this role, prepare examples of how you've effectively communicated regulatory advice or collaborated with cross-functional teams in the past. This will help demonstrate your ability to convey complex information clearly.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or queries from authorities. Think through some scenarios beforehand and be ready to discuss your thought process and decision-making skills in these situations.
✨Highlight Your Analytical Thinking
Prepare to discuss instances where your analytical thinking has led to successful outcomes in regulatory processes. Whether it's managing applications or responding to authority queries, showcasing your problem-solving abilities will set you apart.
