At a Glance
- Tasks: Lead UK regulatory activities and ensure compliance with MHRA and international requirements.
- Company: Join a dynamic pharmaceutical company committed to innovation and compliance.
- Benefits: Enjoy 25-30 days holiday, private healthcare, and a bonus scheme.
- Other info: Hybrid working model with opportunities for professional growth.
- Why this job: Make a real impact in the pharmaceutical industry while advancing your career.
- Qualifications: Degree in Pharmacy or life sciences and 5+ years in Regulatory Affairs.
The predicted salary is between 63000 - 77000 £ per year.
Location: Romford, (Hybrid)
Contract Type: Permanent
Working Hours: Monday - Friday, 8:30am - 5:00pm
Right to work: Please note that Ethypharm is unable to provide sponsorship for this role. Applicants must already have the right to work in the UK.
What you will do: The Senior Regulatory Affairs Officer is responsible for leading UK regulatory and CMC lifecycle activities for assigned products, ensuring compliance with MHRA and applicable EU/international requirements. The role provides strategic regulatory advice, manages complex post-approval submissions, supports business-critical projects, and acts as a technical mentor for junior team members and new starters.
Your key responsibilities include:
- Preparation of regulatory strategies for expediting new registrations and complex post approval changes
- Plan, prepare and compile high quality documentation for new registrations according to CTD requirements (Modules 1 to 5)
- Co-ordinate and/or prepare review, submit and subsequently manage applications to designated Regulatory Authorities in a timely manner
- Liaise with manufacturing, commercial, medical affairs and pharmaceutical development as well as external regulatory contacts (including regulatory agencies) to ensure all regulatory requirements for these submissions are met
- Actively manage regulatory procedures for the review and approval of these submissions
- Provide high quality regulatory advice on most efficient strategy for preparation, submission and approval of these submissions
- Provide forward plans for the preparation, submission and approval of these submissions including timelines for implementation and launch to manage organisational expectations and budgetary requirements (including correct fee payment to the authorities)
About you: You will be an experienced Regulatory Affairs professional with a strong understanding of pharmaceutical regulations and submission requirements. Organised and confident managing multiple priorities, you will work well with colleagues across the business and communicate clearly with regulatory authorities. You will have excellent attention to detail, a practical approach to problem-solving and the confidence to take ownership of your work.
Basic skills and qualifications:
- Educated to degree level, ideally in Pharmacy, chemistry or life sciences
- Minimum of 5 years Regulatory Affairs experience which includes the Preparation of modules for the regulatory dossier in eCTD format, submission of variations, renewals new licence application submissions using national country specific procedures.
- Has good knowledge of CTD dossier writing especially Modules 1 to 3.
What we offer you:
- Holiday - 25 days rising to 30 with length of service plus bank holidays
- Holiday Buy/Sell - an opportunity to buy or sell up to an additional 5 days' holiday
- 5% Bonus - In addition to our competitive salaries, all our employees are entitled to join a discretionary bonus scheme (based on policy eligibility)
- Bravo Benefits Platform - offering a variety of discounts across well-being and lifestyle
- Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on meeting policy eligibility)
- Private Healthcare for yourself and your family (if applicable) with an additional Medicash health cash plan
Senior RA Officer in London employer: Ethypharm
Ethypharm is an exceptional employer located in Romford, offering a hybrid work environment that promotes a healthy work-life balance. With a strong focus on employee growth, we provide comprehensive benefits including generous holiday allowances, a discretionary bonus scheme, and private healthcare options, all within a collaborative culture that values strategic input and mentorship. Join us to be part of a dynamic team where your expertise in regulatory affairs will be recognised and rewarded.
StudySmarter Expert Advice🤫
We think this is how you could land Senior RA Officer in London
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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 Ethypharm.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Ethypharm. 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 Ethypharm is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior RA Officer in London
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 Ethypharm!
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 Ethypharm 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 Ethypharm!
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 Ethypharm, 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 Ethypharm
✨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 Ethypharm 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 Ethypharm’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.
