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- Tasks: Lead regulatory strategy and ensure timely approvals for clinical trials and medical products.
- Company: Join an innovative global pharmaceutical company making a difference in healthcare.
- Benefits: Enjoy a temporary contract with potential for growth and valuable industry experience.
- Why this job: Be part of a dynamic team impacting product development and regulatory compliance.
- Qualifications: Experience in Regulatory Affairs, particularly with CTA and MA, is essential.
- Other info: Equal Opportunities Employer committed to diversity and inclusion.
The predicted salary is between 43200 - 72000 £ per year.
An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the region and make sure that regulatory deadlines and approvals are achieved.
Other responsibilities include:
- Developing, contributing and ensuring the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
- Contributing regulatory guidance in order to enhance product development.
- Ensuring that product development is aligned with the company’s strategy business model as well as global regulatory requirements.
- Acting as a point of contact between the company and regulatory agencies whilst pertaining important information.
Requirements:
- Previous experience in Regulatory Affairs and Compliance particularly within the pharmaceutical industry.
- A proven background working on CTA, MA.
- Provision of scientific advisory support is essential.
- Proven ability to create regulatory affairs strategy.
- Exposure to Regulatory Affairs legislation and procedures.
- Strong communication and interpersonal skills.
Regulatory Affairs Manager employer: Park Street People
Contact Detail:
Park Street People Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who work in regulatory affairs. Attend industry conferences or webinars to meet potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to clinical trials and medical products in the EU. This knowledge will not only boost your confidence but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in regulatory affairs, particularly your work with Clinical Trial Applications (CTA) and Marketing Authorisations (MA). Be ready to provide examples of how you successfully navigated regulatory challenges in past roles.
✨Tip Number 4
Showcase your communication and interpersonal skills by preparing for behavioural interview questions. Think of scenarios where you effectively collaborated with cross-functional teams or liaised with regulatory agencies to achieve project goals.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Regulatory Affairs Manager position. Make sure you understand the key responsibilities and requirements, particularly around CTA and EU experience.
Tailor Your CV: Customise your CV to highlight relevant experience in Regulatory Affairs, especially within the pharmaceutical industry. Emphasise your background with clinical trials and regulatory strategy.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the company's goals. Mention specific experiences that align with the role's requirements.
Highlight Communication Skills: Since strong communication and interpersonal skills are essential for this role, provide examples in your application that demonstrate your ability to liaise effectively with regulatory agencies and stakeholders.
How to prepare for a job interview at Park Street People
✨Know Your Regulatory Framework
Familiarise yourself with the latest regulations and guidelines relevant to the pharmaceutical industry, especially those pertaining to Clinical Trial Applications (CTA) and Marketing Authorisations (MA). Being able to discuss these in detail will demonstrate your expertise and commitment to the role.
✨Showcase Your Experience
Prepare specific examples from your previous roles that highlight your experience in regulatory affairs. Discuss how you successfully navigated regulatory challenges and contributed to product development, as this will illustrate your capability to handle the responsibilities of the position.
✨Communicate Effectively
Strong communication skills are essential for this role. Practice articulating complex regulatory concepts clearly and concisely. Be ready to explain how you would act as a liaison between the company and regulatory agencies, ensuring that all parties are aligned.
✨Align with Company Strategy
Research the company's business model and strategic goals. Be prepared to discuss how your regulatory strategies can support their objectives and ensure compliance with global requirements. This shows that you understand the bigger picture and are invested in the company's success.
