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- Tasks: Lead regulatory compliance for pharmaceutical products and manage submission processes.
- Company: Join a dynamic team at Syri Pharma, a leader in the pharmaceutical industry.
- Benefits: Enjoy competitive pay, professional growth opportunities, and a collaborative work environment.
- Why this job: Make a real impact in healthcare while working with cutting-edge pharmaceutical regulations.
- Qualifications: 6+ years in regulatory affairs, with strong knowledge of EU directives and ICH guidelines.
- Other info: Ideal for those passionate about compliance and quality assurance in pharmaceuticals.
The predicted salary is between 43200 - 72000 £ per year.
Job Description ROLE: Regulatory Compliance Manager (Pharmaceuticals) ESSENTIAL Well-developed regulatory compliance experience in the pharmaceutical industry. At least 6 years of relevant experience in the pharmaceutical industry, with preferably 4 years in compliance in Regulatory Affairs preferably with some Quality Assurance experience Well developed understanding of the medicines manufacturing testing and release Good knowledge of EU directives, ICH guidelines.UK requirements PRIMARY RESPONSIBILITIES Manage the preparation and review of dossiers for MA variation applications, MA renewals and other regulatory post licensing submission in all territories in which Syri/ Syri Pharma holds marketing authorisations and ensures timely submission of applications meeting pre agreed timelines Manage the preparation and review of responses to requests for further information from regulatory authorities for all post approval regulatory submissions. Liaise and follow up with regulatory authorities submissions and regulatory issues. Maintaining the product life cycle once the licence is approved. Responsible for the preparation, maintenance and review of product approval packages. Ensure with internal and external contacts tha…
Regulatory Affairs Manager employer: B&S Group
Contact Detail:
B&S Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Make sure to highlight your specific experience in regulatory compliance within the pharmaceutical industry. Focus on your achievements and how they align with the responsibilities listed in the job description.
✨Tip Number 2
Network with professionals in the regulatory affairs field. Attend industry conferences or webinars where you can connect with others who may have insights or even referrals for the position.
✨Tip Number 3
Stay updated on the latest EU directives and ICH guidelines. Being knowledgeable about current regulations will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 4
Prepare to discuss specific examples of how you've managed regulatory submissions and liaised with authorities in your previous roles. This will show your practical experience and problem-solving skills.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Highlight Relevant Experience: Make sure to emphasize your regulatory compliance experience in the pharmaceutical industry. Detail your 6+ years of relevant experience and specifically mention any roles related to compliance in Regulatory Affairs and Quality Assurance.
Showcase Knowledge of Regulations: Demonstrate your understanding of EU directives, ICH guidelines, and UK requirements. Use specific examples from your past work to illustrate how you have applied this knowledge in real-world scenarios.
Detail Your Responsibilities: In your application, clearly outline your previous responsibilities that align with the primary responsibilities listed in the job description. Mention your experience in managing dossier preparations, responding to regulatory authorities, and maintaining product life cycles.
Tailor Your Application: Customize your CV and cover letter to reflect the specific requirements of the Regulatory Compliance Manager role. Use keywords from the job description to ensure your application stands out to hiring managers.
How to prepare for a job interview at B&S Group
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of EU directives and ICH guidelines during the interview. Prepare specific examples from your past experience that demonstrate your expertise in regulatory compliance within the pharmaceutical industry.
✨Discuss Your Experience with Dossier Preparation
Be ready to discuss your experience in managing the preparation and review of dossiers for marketing authorization applications. Share details about the types of submissions you've handled and how you ensured timely submissions.
✨Emphasize Your Communication Skills
Since liaising with regulatory authorities is a key responsibility, emphasize your communication skills. Provide examples of how you've effectively managed relationships with regulatory bodies and resolved any issues that arose.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions related to regulatory challenges. Think about past situations where you had to navigate complex regulatory requirements and be prepared to explain your thought process and the outcomes.
