At a Glance
- Tasks: Lead regulatory submissions and ensure compliance for innovative pharmaceutical products.
- Company: Join a dynamic pharmaceutical company focused on impactful healthcare solutions.
- Benefits: Competitive salary, professional development, and a supportive work environment.
- Other info: Opportunity to manage complex projects and grow your career in a fast-paced industry.
- Why this job: Make a difference in healthcare by navigating complex regulatory landscapes.
- Qualifications: Degree in life sciences and substantial regulatory experience required.
Select Pharma Recruitment provided pay range
This range is provided by Select Pharma Recruitment. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
Direct message the job poster from Select Pharma Recruitment
Responsibilities
- Responsible for the provision of full regulatory input and support for assigned products across the submission and assessment phase which includes the preparation, submission and response to questions for new Marketing Authorisation Applications. Manages increasingly complex submissions making decisions independently and with minimal referral to line manager.
- Ensure regulatory submissions are made on time and any delays are communicated to all relevant stakeholders in a timely manner so as to minimize impact to the business
- Provide regulatory input on pharmaceutical development and CMC and review quality documentation to ensure regulatory compliance with UK and EU legislation
- Provide regulatory input on artworks and ensure approval in time for product launch and compliance with legislation and guidelines.
Qualifications and Required Experience
- Degree in a suitable scientific discipline (biological/chemistry/life sciences).
- Substantial regulatory experience across the full product lifecycle.
- Strong due diligence and report writing; ability to write up a report with the information found (deficiencies, errors etc in the dossier or territory specific updates needed prior to submission)
- Strong CMC regulatory experience, including preparation and review of Module 3 CTD.
- Solid understanding of pharmaceutical manufacturing processes, analytical methods and regulatory expectations for CMC compliance.
- Broad experience of managing relevant regulatory submissions, with demonstrated ability to work independently and manage complex projects.
- In depth knowledge of UK and European regulatory affairs legislation and guidance.
- Planning and organisation skills - Ability to handle multiple tasks/projects and manage priorities accordingly.
- Able to work under pressure and to strict deadlines.
- A confident credible communicator with good negotiation skills.
- Able to build relationships at all levels of the business.
- Excellent written communication skills with attention to detail.
- Able to independently identify and initiate tasks/projects.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Science
Industries
- Pharmaceutical Manufacturing
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Principal Regulatory Affairs Officer employer: Select Pharma Recruitment
As a Principal Regulatory Affairs Officer at Select Pharma Recruitment, you will thrive in a dynamic and supportive work environment that prioritises employee growth and development. With a strong focus on collaboration and innovation, the company offers competitive pay, comprehensive benefits, and opportunities to engage in meaningful projects that impact the pharmaceutical industry. Located in a vibrant area, you'll enjoy a work culture that values work-life balance and encourages professional advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Regulatory Affairs Officer
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Select Pharma Recruitment. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Select Pharma Recruitment.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Select Pharma Recruitment. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Select Pharma Recruitment is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Principal Regulatory Affairs Officer
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Select Pharma Recruitment!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Select Pharma Recruitment that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Select Pharma Recruitment!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Select Pharma Recruitment, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Select Pharma Recruitment
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Select Pharma Recruitment that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Select Pharma Recruitment’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
