At a Glance
- Tasks: Develop regulatory strategies and provide guidance for product development in the Consumer Health sector.
- Company: Leading multinational Consumer Health client with a hybrid work model.
- Benefits: Competitive salary, flexible working, and opportunities for professional growth.
- Other info: Exciting opportunity to work on innovative projects with a focus on compliance and quality.
- Why this job: Join a dynamic team and influence product compliance across the EMEA region.
- Qualifications: 6-8 years of experience in regulatory affairs and a relevant degree in Life Science or Chemistry/Biology.
The predicted salary is between 50000 - 60000 £ per year.
PE Global are currently recruiting for a Regulatory Affairs Specialist for an initial 6 month contract role with a leading multinational Consumer Health client based in Reading – hybrid (2/3 days per week in the office).
Responsible for the development of CMC/technical regulatory strategies across the EMEA region providing regulatory input and technical guidance on regional regulatory requirements to product development teams within the Self Care franchise.
Responsibilities
- Provides strategic regulatory input and technical guidance on regional regulatory requirements to product stakeholders within LCM and growth & innovation.
- Participates in cross-functional project teams to define development program requirements and risks.
- Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines in EMEA.
- Maintains awareness of current regulations and anticipates implications and opportunities because of changes to the relevant regulatory environments.
- Communicates changes to appropriate management and cross functional experts as appropriate.
- Ensures that all products comply with local regulatory and quality system requirements.
- Ensures quality and compliance in all actions.
- Participates in the development and implementation of, and maintains compliance with, all applicable Processes.
- Ensures that the enterprise Regulatory systems are accurate and fully maintained.
- Ensures any compliance issues are reviewed and escalated, and relevant corrective/preventative actions are implemented locally.
- Identifies and/or implements regional process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
- Evaluates deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.
Requirements
- Requires 6-8 Years Work Experience.
- Relevant Bachelor's Degree or higher in Life Science or Chemistry/Biology.
- Expertise of EU WS and MR-DC in line with the Pharmaceutical Directive and associated guideline.
- Specific skills in management of EU procedures are a must.
- Desirable to have experience in leading early-stage innovation RA deliverables such as determining classification status, regulatory strategy for medicinal products and implementation of the strategy.
- Knowledge of regulatory frameworks and external environments in the EU and wider EMEA, and the ability to apply these to regulatory solutions throughout the product lifecycle.
- Strong project management skills.
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 the UK.
Regulatory Affairs Specialist employer: PE Global
PE Global is an exceptional employer, offering a dynamic work environment in Reading that fosters collaboration and innovation within the Consumer Health sector. With a strong commitment to employee development, we provide opportunities for growth through cross-functional projects and strategic regulatory initiatives, ensuring our team members are equipped to thrive in their careers. Our hybrid working model promotes a healthy work-life balance, making PE Global a rewarding place to advance your professional journey.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like PE Global.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at PE Global.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at PE Global. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at PE Global
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with PE Global.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help PE Global achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
