At a Glance
- Tasks: Lead regulatory submissions and negotiate with agencies to fast-track drug approvals.
- Company: Join a leading global pharmaceutical manufacturer based in London, shaping the future of healthcare.
- Benefits: Enjoy competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Ideal for those passionate about advancing healthcare and making a difference in patients' lives.
- Why this job: Make a significant impact in a key role while collaborating with diverse teams in a dynamic environment.
- Qualifications: 6-10 years in regulatory affairs, with European experience and strong communication skills required.
The predicted salary is between 72000 - 108000 £ per year.
Job Description
Title: Global Associate Director, Regulatory Affairs
Job Type: Full-time permanent position
Location: West London, UK – 3x a week in the office
Salary: £90,000 - £100,000 + Car Allowance + Bonus
Working for one of the industry’s leading pharmaceutical companies, this is a fantastic opportunity to provide expert regulatory knowledge from pre-clinical through clinical studies to initial registration in key global markets.
Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission.
Role responsibilities:
- Drive global Regulatory Affairs strategies for the portfolio, including managing internal and external stakeholders.
- Lead interactions with the health authorities/ local agencies – MHRA, EMA & FDA. This will be including pre submission meetings, pre-IND meetings, Scientific advice and type B/C meetings with the FDA.
- Support both early and late-stage development activities CTAs, IND, ODD, PIPS, IND, IMPD, and initial MAAs.
- Confident in doing submissions in global markets with a main focus on the UK, EU, US, and ROW.
- Support and lead cross functional team discussions with medical, quality, PV, and other departments.
Requirements:
- A scientific degree is essential.
- Proven track record of leading successful European (CP, DCP, MRP), European national and US submissions.
- Confident in leading global RA strategies.
- Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory strategy document (GRSD) delivery.
- Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs.
- Ability to clearly convey and exchange information with internal and external stakeholders.
This role is a very senior role within the regulatory team. You will need at least 8 years of relevant regulatory experience, ideally within a large pharmaceutical business.
All the Regulatory team members attend the office 3x a week, so you would be expected to attend the office on a hybrid basis in White City, London.
For more information, please reach out to me at lucy.kirkaldy@cpl.com
Associate Director Regulatory Affairs in City of London employer: Cpl Life Sciences
Join a leading global pharmaceutical manufacturing organisation in London, where your role as Associate Director of Regulatory Affairs will be pivotal in shaping the future of our regulatory function. We pride ourselves on fostering a collaborative work culture that values innovation and professional growth, offering extensive opportunities for career advancement and development within a dynamic environment. With a commitment to employee well-being and a focus on impactful work, this is an exceptional opportunity for those seeking meaningful and rewarding employment in the pharmaceutical sector.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director Regulatory Affairs in City of London
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Cpl Life Sciences. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Cpl Life Sciences.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Cpl Life Sciences. 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 Cpl Life Sciences is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Associate Director Regulatory Affairs in City of 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 Cpl Life Sciences!
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 Cpl Life Sciences 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 Cpl Life Sciences!
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 Cpl Life Sciences, 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 Cpl Life Sciences
✨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 Cpl Life Sciences 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 Cpl Life Sciences’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.
