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- Tasks: Manage regulatory submissions and provide expert advice to ensure compliance.
- Company: Join a leading UK pharmaceutical firm focused on innovative solutions for patients.
- Benefits: Enjoy flexible working options and a collaborative team environment.
- Why this job: Make a real impact in healthcare while developing your regulatory expertise.
- Qualifications: Experience in regulatory affairs, strong communication skills, and MS-Office proficiency required.
- Other info: This is a contract role with opportunities for professional growth.
The predicted salary is between 48000 - 72000 £ per year.
Senior Regulatory Affairs Associate – Contract – Pharmaceuticals
Do you relish the opportunity to work with an international pharmaceutical organisation based in the UK? If yes, then this is the assignment for you!
Our client specializes in delivering medicines for patients with swallowing difficulties, across a range of therapeutic areas.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Independently execute variations for existing marketing authorisations to be submitted as per the relevant competent authorities’ requirements and in compliance with local laws and regulations, including the compilation of responses to authority questions within agreed timescales. Active participation as regulatory affairs representative in meetings with internal & external stakeholders, working cross-functionally to achieve the business goal. As a product owner, providing comprehensive regulatory advice to support the business including change control SME.
- Develop and approve product information text in compliance with SOPs and relevant guidelines for variations.
- Maintenance of regulatory systems and provide timely notification to internal & external stakeholders in line with KPIs to ensure compliance with the marketing authorisation.
- Support associate team members.
Desirable Experience:
- Current awareness of legal framework and forthcoming legislation that may affect the business.
- Understanding of the workings of global competent authorities.
- Good understanding of variations in UK and EU; knowledge globally would be beneficial.
- Good CMC knowledge; eCTD beneficial.
- Shows initiative and drive, particularly when faced with a problem.
- Demonstrates good planning abilities with flexibility and agility.
- Excellent written and verbal communication skills essential, including good attention to detail.
- MS-Office knowledge essential.
If this role is of interest to you, please apply now!
Seniority level
- Mid-Senior level
Employment type
- Contract
Job function
- Legal
- Industries: Staffing and Recruiting
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Senior Regulatory Affairs Associate employer: QCS Staffing
Contact Detail:
QCS Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines in the pharmaceutical industry, especially those related to marketing authorisations in the UK and EU. This knowledge will not only boost your confidence but also demonstrate your commitment to staying updated in your field.
✨Tip Number 2
Network with professionals in regulatory affairs through platforms like LinkedIn or industry-specific events. Engaging with others in the field can provide valuable insights and may even lead to referrals for the position you're interested in.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed regulatory submissions or variations in past roles. Highlighting your experience with cross-functional teams will show that you can effectively collaborate to achieve business goals.
✨Tip Number 4
Research the company’s recent projects and initiatives in the pharmaceutical sector. Being knowledgeable about their work will allow you to tailor your discussions during interviews and show genuine interest in contributing to their mission.
We think you need these skills to ace Senior Regulatory Affairs Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in the pharmaceutical sector. Emphasise your understanding of UK and EU regulations, as well as any experience with marketing authorisations.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention specific experiences that demonstrate your ability to execute variations for marketing authorisations and your skills in cross-functional collaboration.
Highlight Key Skills: In your application, emphasise your excellent written and verbal communication skills, attention to detail, and ability to work under pressure. These are crucial for the Senior Regulatory Affairs Associate position.
Showcase Initiative and Problem-Solving: Provide examples in your application that illustrate your initiative and problem-solving abilities. This could include situations where you successfully navigated regulatory challenges or improved processes within your team.
How to prepare for a job interview at QCS Staffing
✨Know Your Regulations
Familiarise yourself with the current legal frameworks and upcoming legislation relevant to the pharmaceutical industry. Being able to discuss these topics confidently will demonstrate your expertise and commitment to the role.
✨Showcase Your Cross-Functional Experience
Prepare examples of how you've successfully collaborated with various stakeholders in previous roles. Highlighting your ability to work cross-functionally will show that you can effectively represent regulatory affairs within the organisation.
✨Demonstrate Attention to Detail
Since this role requires excellent written communication skills, be ready to discuss how you ensure accuracy in your work. Bring examples of documents or reports you've prepared that required meticulous attention to detail.
✨Prepare for Scenario Questions
Anticipate questions that may ask how you would handle specific regulatory challenges or changes. Think through your problem-solving strategies and be ready to articulate your thought process clearly during the interview.
