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For Companies At a Glance
- Tasks: Lead regulatory submissions and manage compliance for innovative neurology and injectables products.
- Company: Join a global pharma leader focused on groundbreaking solutions in neurology and injectables.
- Benefits: Enjoy hybrid working with 3 days in the office and competitive salary.
- Why this job: Be part of a dynamic team making a real impact in healthcare innovation.
- Qualifications: 10+ years in regulatory affairs, experience with generics or R&D, and knowledge of neurology injectables.
- Other info: This is a permanent role; remote work is not an option.
The predicted salary is between 54000 - 84000 £ 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
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Associate Director Regulatory Affairs employer: Star People
Contact Detail:
Star People Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Regulatory Affairs
✨Tip Number 1
Make sure to highlight your extensive regulatory experience, especially if you have over 10 years in the field. Tailor your discussions to emphasize your familiarity with generics or R&D businesses, as this is crucial for the role.
✨Tip Number 2
Familiarize yourself with the latest guidelines and requirements for PIP submissions to EMA authorities. Being able to discuss recent changes or challenges in this area can set you apart during interviews.
✨Tip Number 3
If you have experience with Neurology and injectables, prepare specific examples of your past projects or successes in these areas. This will demonstrate your relevant expertise and make a strong case for your candidacy.
✨Tip Number 4
Since this role requires hybrid working in Slough, ensure you are ready to discuss your availability and commitment to being in the office three days a week. Showing enthusiasm for the work environment can positively influence your application.
We think you need these skills to ace Associate Director Regulatory Affairs
Some tips for your application 🫡
Highlight Relevant Experience: Make sure to emphasize your 10+ years of regulatory experience, particularly in generics or R&D. Detail your involvement with PIP submissions to EMA authorities and CTIS submissions, as this is crucial for the role.
Showcase Your Portfolio Knowledge: Discuss your previous experience with Neurology and injectables portfolios. If you have any experience in respiratory, mention it as a desirable asset that could set you apart from other candidates.
Tailor Your CV and Cover Letter: Customize your CV and cover letter to reflect the specific requirements of the Associate Director Regulatory Affairs position. Use keywords from the job description to demonstrate your fit for the role.
Clarify Your Work Eligibility: Since the company cannot sponsor work visas, clearly state your valid right to work in your application. This will help avoid any misunderstandings during the hiring process.
How to prepare for a job interview at Star People
✨Showcase Your Regulatory Experience
Make sure to highlight your 10+ years of regulatory experience during the interview. Discuss specific projects or submissions you've led, especially those related to PIP and CTIS submissions to EMA authorities.
✨Demonstrate Knowledge of Neurology and Injectables
Since the role focuses on Neurology and injectables, be prepared to discuss your previous experience with these portfolios. Share examples of how you've contributed to the success of similar products in the past.
✨Prepare for Questions on Due Diligence
Expect questions regarding your experience with due diligence processes. Be ready to explain how you approach these assessments and any challenges you've faced in the past.
✨Understand the Hybrid Working Model
As this position requires hybrid working, clarify your availability for the Slough office. Show that you are flexible and can effectively balance remote work with in-office responsibilities.
