At a Glance
- Tasks: Lead global labelling strategies and collaborate with cross-functional teams to ensure effective communication.
- Company: Freyr, a global leader in Regulatory Solutions for Life Sciences.
- Benefits: 12-month fixed term role with competitive salary and professional growth opportunities.
- Other info: Join a dynamic team focused on continuous improvement and innovation.
- Why this job: Make a real impact in the pharmaceutical industry while developing your regulatory expertise.
- Qualifications: 8+ years in pharma, with strong labelling and strategic thinking skills.
The predicted salary is between 63000 - 77000 £ per year.
About Freyr
Freyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance.
We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Job Title
- Associate Director - Regulatory Labelling
- Global Labeling Lead
Location
This is for a 12 month fixed term role.
Job Description
- Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation.
- Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content.
- Precedent Search and Labeling Trends - Conducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Client products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU Sm PC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Client products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals.
- Working within Labeling Team and GRA - Represents Global Labeling at Global Regulatory Team (GRT) - Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met.
- Represents global labeling in departmental and cross-functional task-forces and initiatives.
- Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes.
- Vendor Management - Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.
- Continuous Improvement - Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.
Education & Competencies (Technical and Behavioral)
- BSc degree, preferred; BA accepted.
- Advanced scientific degree (MSc, Ph D, or Pharm D) preferred.
- 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
- Strategic Thinking - Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management.
- Demonstrates an understanding of core business aspect.
- Communication - Ability to effectively collaborate with global cross-functional teams.
- Ability to use communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation formats.
- Ability to promote regulatory decisions across global cross-functional teams.
Associate Director Regulatory Affairs in Cambridge employer: Freyr Solutions
As a leading employer in the Life Sciences sector, we offer a dynamic work environment that fosters innovation and collaboration. Our commitment to employee growth is evident through continuous training opportunities and a culture that values quality and integrity. Located in a vibrant area, our team enjoys a supportive atmosphere where every contribution is recognised, making it an ideal place for professionals seeking meaningful and rewarding careers.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director Regulatory Affairs in Cambridge
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Freyr Solutions.
We think you need these skills to ace Associate Director Regulatory Affairs in Cambridge
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Freyr Solutions.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Freyr Solutions. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Freyr Solutions
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Freyr Solutions.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Freyr Solutions achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
