Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory activities for unlicensed medicines and guide project teams.
- Company: Join a dynamic global leader in the pharmaceutical and healthcare sector based in Ireland.
- Benefits: Enjoy a competitive salary, comprehensive benefits, and opportunities for growth.
- Why this job: Be part of a mission-driven company making a real impact on global health.
- Qualifications: Regulatory experience, proficiency in Microsoft Office, and client-facing skills required.
- Other info: Ideal for those passionate about unlicensed medicines and regulatory strategy.
The predicted salary is between 43200 - 72000 £ per year.
Regulatory Affairs Associate Director | Hayes
Our client is seeking an experienced Regulatory Affairs Associate Director who will manage and oversee the regulatory activities that underpin the supply of unlicensed and pre-reimbursement medicines into the global market.
Company Overview:
We are working with a leading service provider within the pharmaceutical and healthcare sector headquartered in Ireland; their three trading divisions work in synergy to support communities with the medicines and support that they need.
- Global company that is constantly growing
- Competitive salary and comprehensive benefits package
Job Overview:
- Act as an in-house regulatory expert, advising and supporting the Business Units and project teams
- Providing guidance regarding current unlicensed regulations and guidance (EU, UK, and ROW) to internal and external stakeholders
- Creating and maintaining Regulatory Intelligence related to unlicensed product supply as well as understanding and communicating the impact of new, existing and pending regulations, guidelines, and standards
- Oversight and ownership of regulatory elements of all packaging and labelling activities for the GMP activities associated with unlicensed medicines supply
- Drafting and maintaining regulatory procedures as required
To be successful:
- Regulatory experience and experience in developing regulatory strategy
- Ability to work proficiently within Microsoft Office Suite systems (Word, Excel, and PowerPoint)
- Prior experience of working within the Unlicensed Medicines supply service sector is ideal
- Prior experience of preparing group or cohort regulatory submissions for unlicensed medicines supply (e.g. cATU in France, CUP in Germany, EAMS in UK)
- Experience within a client-facing, service role
How to apply:
If you like the sound of this opportunity and you’re ready to take the next step in your career, we would love to hear from you! Please click the \’Easy Apply\’ button or contact Danny Dorward on 01225 336 335 for more information.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance and Science
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Contact Detail:
Star People Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with unlicensed medicines. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and regulations.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks for unlicensed medicines in the EU, UK, and other regions. This knowledge will not only help you in interviews but also demonstrate your commitment to understanding the role's requirements.
✨Tip Number 3
Prepare to discuss your previous experiences in regulatory strategy development and client-facing roles. Be ready to provide examples of how you've successfully navigated complex regulatory environments in the past.
✨Tip Number 4
Showcase your proficiency in Microsoft Office Suite by being prepared to discuss how you've used these tools in your previous roles. Highlight any specific projects where your skills made a significant impact on regulatory submissions or documentation.
We think you need these skills to ace Associate Director Regulatory Affairs
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of an Associate Director in Regulatory Affairs. Familiarise yourself with the specific regulatory frameworks mentioned in the job description, such as EU, UK, and ROW regulations.
Tailor Your CV: Highlight your relevant experience in regulatory affairs, especially any work related to unlicensed medicines. Use specific examples that demonstrate your ability to develop regulatory strategies and manage compliance.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role. Mention how your background aligns with the company's mission and the specific requirements of the position.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or typos. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Star People
✨Showcase Your Regulatory Expertise
Make sure to highlight your experience in regulatory affairs, especially in unlicensed medicines. Be prepared to discuss specific regulations and how you've navigated them in previous roles.
✨Demonstrate Your Strategic Thinking
Discuss your approach to developing regulatory strategies. Provide examples of how you've successfully implemented these strategies in past projects, particularly in relation to unlicensed product supply.
✨Familiarise Yourself with Current Regulations
Stay updated on the latest EU, UK, and ROW regulations regarding unlicensed medicines. Being able to reference recent changes or trends during the interview will show your commitment and knowledge in the field.
✨Prepare for Client-Facing Scenarios
Since the role involves client interaction, be ready to share experiences where you've effectively communicated complex regulatory information to clients or stakeholders. This will demonstrate your ability to handle a service-oriented role.
