Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Join us as a Regulatory Scientist, ensuring smooth regulatory submissions and approvals for innovative pharma products.
- Company: PE Global is a leading multinational Pharma client, dedicated to advancing healthcare solutions.
- Benefits: Enjoy hybrid work options, competitive pay, and the chance to make a real impact in healthcare.
- Why this job: Be part of a dynamic team, shaping regulatory strategies that directly affect patient care and product success.
- Qualifications: Bachelor’s degree in a scientific field with 1-3 years of relevant experience in regulatory affairs.
- Other info: Candidates must have the right to work in the UK; no visa sponsorship available.
The predicted salary is between 36000 - 60000 £ per year.
PE Global are currently recruiting for a Regulatory Affairs with European Regulatory experience for a contract role with a leading multinational Pharma client, based in Bracknell – hybrid. The GRA-EMEA or GRA-Americas Regional Regulatory Scientist is accountable to provide regional regulatory expertise in supporting the delivery of high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s). Responsibilities Provide region/country input and review of global strategic plans and global/regional submission plan and documents. Provide support to Regional Regulatory Lead Scientist during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region). Ensure approval and delivery of content for local regulatory submissions, engaging cross functional partners in contributing to development of submission content. Provide support to Regional Regulatory Lead Scientist for meetings and interactions with regulators in assigned region and engage cross functional partners to contribute to regulator interactions. Support development of local/regional labelling strategy (product information and packaging) and help to network for alignment across region/affiliate team to enable timely completion of registration milestones (i.e. submission, approval, and launch). Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling in region/country. Provide support to Regional Regulatory Lead Scientist in leading team during negotiation with regulators by providing responses to labelling questions. Ensure compliance with all applicable regulations and internal quality systems. Provide up-to-date expertise on regional registration procedures. Interpret and anticipate impact of new guidelines and work with Regional Regulatory Lead Scientist to initiate change in response to changing environment. Own all regulatory activities in support of assigned marketed product(s) in the region/country. Ensure the registration needs for local patients in clinical trials are met for countries in the region/country. Requirements Ideally someone with CTA experience scientific advice or PIP or marketing authorisation or post-approval. Clinical experience is a must. Bachelor’s degree in scientific or health sciences discipline Industry-related or other relevant work experience in 1-3 years Knowledge of local/regional regulatory procedures and practices Knowledge of the drug development process Ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes Ability to assess and propose ways to manage risk in a highly regulated environment Demonstrated strong written, spoken and presentation communication Developing negotiation and influence skills Demonstrated attention to detail Demonstrated ability to work independently Interested candidates should submit an updated CV. Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK41bf1e1f-b16b-4260-a40a-17c77a06fd15
Regulatory Scientist employer: PE Global
Contact Detail:
PE Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Scientist
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the European market. Understanding the nuances of local regulations will not only boost your confidence but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in the pharmaceutical industry. Engaging with others can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Stay updated on recent changes in regulatory policies and practices. Being knowledgeable about current trends and challenges in the industry will help you stand out during interviews and discussions.
✨Tip Number 4
Prepare to discuss your problem-solving skills and how you've successfully navigated regulatory challenges in the past. Highlighting your ability to work collaboratively with cross-functional teams will show that you're a great fit for the role.
We think you need these skills to ace Regulatory Scientist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly any European regulatory experience. Use keywords from the job description to demonstrate that you meet the specific requirements.
Craft a Strong Cover Letter: Write a cover letter that clearly outlines your understanding of the role and how your background aligns with the responsibilities listed. Mention your experience with regulatory submissions and any specific achievements that showcase your expertise.
Highlight Relevant Skills: In your application, emphasise skills such as attention to detail, communication, and negotiation abilities. Provide examples of how you've successfully navigated regulatory processes or worked with cross-functional teams.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in regulatory roles.
How to prepare for a job interview at PE Global
✨Know Your Regulatory Landscape
Familiarise yourself with the specific regulatory requirements and procedures in the European market. Understanding the nuances of local regulations will demonstrate your expertise and readiness for the role.
✨Showcase Your Teamwork Skills
Highlight your ability to collaborate with cross-functional teams. Provide examples of how you've successfully worked with others to achieve regulatory goals, as teamwork is crucial in this role.
✨Prepare for Scenario-Based Questions
Anticipate questions that may ask you to solve hypothetical regulatory challenges. Think through your problem-solving process and be ready to discuss how you would approach these situations.
✨Demonstrate Attention to Detail
Regulatory roles require a keen eye for detail. Be prepared to discuss past experiences where your attention to detail made a significant impact on a project or submission.
