(Senior) Manager, Regulatory Affairs

(Senior) Manager, Regulatory Affairs

Freelance 56000 - 68000 € / year (est.) Home office (partial)
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At a Glance

  • Tasks: Lead regulatory strategy and collaborate with global teams for successful product approvals.
  • Company: Leading pharmaceutical company with a focus on innovation and compliance.
  • Benefits: Competitive hourly rate, flexible hybrid work, and opportunities for professional growth.
  • Other info: Join a dynamic team and make a difference in the pharmaceutical industry.
  • Why this job: Shape the future of healthcare by driving impactful regulatory strategies across Europe.
  • Qualifications: Degree in pharmacy or related field, plus extensive regulatory affairs experience.

The predicted salary is between 56000 - 68000 € per year.

Location: Maidenhead/Remote (hybrid)

Duration: 12 months initial (FOUR days per week / 0.8 FTE)

Rate: £70-85 per hour (based on experience)

We are working with a leading pharmaceutical company who are seeking an experienced Senior Manager, Regulatory Affairs to shape and drive regulatory strategy across the Europe Area. This high-impact role will work across development and marketed products, partnering closely with global teams, affiliates and health authorities to ensure successful regulatory outcomes.

Key Responsibilities

  • Lead the development and implementation of regulatory strategies and risk assessments for assigned products across the Europe Area
  • Represent regional regulatory requirements within global regulatory project teams to ensure appropriate consideration in global strategy
  • Collaborate with affiliate Regulatory Affairs teams to guide submissions, health authority interactions and life-cycle management activities
  • Assess scientific data for regulatory submissions, identify gaps, and develop mitigation strategies to support approvals
  • Monitor evolving European legislation and lead the development of regulatory responses and policy implementation

Skills Experience Required

Degree in pharmaceutical sciences or related field.

(Senior) Manager, Regulatory Affairs employer: Lorien

As a leading pharmaceutical company, we pride ourselves on fostering a dynamic and inclusive work culture that prioritises employee growth and development. Our hybrid working model allows for flexibility, enabling you to balance your professional and personal life while contributing to impactful regulatory strategies across Europe. With competitive rates and a commitment to innovation, we offer a rewarding environment where your expertise can truly make a difference.

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Contact Detail:

Lorien Recruiting Team

StudySmarter Expert Advice🤫

We think this is how you could land (Senior) Manager, Regulatory Affairs

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 European regulations and recent changes in legislation. We want you to shine when discussing how you can shape and drive regulatory strategy!

Tip Number 3

Showcase your experience with real-life examples during interviews. We love hearing about how you've successfully navigated regulatory challenges in the past—make it memorable!

Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. We’re here to help you every step of the way!

We think you need these skills to ace (Senior) Manager, Regulatory Affairs

Regulatory Strategy Development
Risk Assessment
Collaboration with Global Teams
Health Authority Interactions
Life-Cycle Management
Scientific Data Assessment
Gap Analysis

Some tips for your application 🫡

Tailor Your CV:Make sure your CV is tailored to the role of Senior Manager, Regulatory Affairs. Highlight your relevant experience in regulatory strategy and any specific achievements that align with the job description. We want to see how you can bring value to our team!

Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Share your passion for regulatory affairs and how your background aligns with the responsibilities outlined in the job description. Let us know what excites you about working with us!

Showcase Your Collaboration Skills:Since this role involves working closely with global teams and health authorities, make sure to highlight your collaboration skills. Share examples of how you've successfully partnered with others in previous roles. We love seeing teamwork in action!

Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy – just a few clicks and you’re done!

How to prepare for a job interview at Lorien

Know Your Regulatory Stuff

Make sure you brush up on the latest European regulations and guidelines relevant to the pharmaceutical industry. Being able to discuss recent changes or trends will show that you're not just knowledgeable but also proactive in staying updated.

Showcase Your Strategic Thinking

Prepare examples of how you've developed and implemented regulatory strategies in the past. Use the STAR method (Situation, Task, Action, Result) to clearly articulate your thought process and the impact of your decisions.

Collaborate Like a Pro

Since this role involves working with global teams and affiliates, be ready to discuss your experience in cross-functional collaboration. Highlight specific instances where your teamwork led to successful regulatory outcomes.

Ask Insightful Questions

Prepare thoughtful questions about the company's regulatory challenges and goals. This not only shows your interest in the role but also gives you a chance to demonstrate your understanding of the regulatory landscape.