At a Glance
- Tasks: Lead regulatory strategy and manage submissions for innovative pharmaceutical products.
- Company: Fast-growing entrepreneurial pharmaceutical company with a dynamic culture.
- Benefits: Competitive salary, flexible working, and opportunities for professional growth.
- Other info: Join a collaborative team and thrive in a hybrid work environment.
- Why this job: Make a real impact in the pharmaceutical industry while shaping regulatory strategies.
- Qualifications: Proven experience in regulatory affairs and strong leadership skills.
The predicted salary is between 70000 - 90000 £ per year.
We are supporting a fast-growing, entrepreneurial pharmaceutical company in its search for a Senior Regulatory Specialist to take ownership of regulatory strategy and lifecycle management across its portfolio. This is a senior-level opportunity for an experienced Regulatory Affairs professional who has operated with a high degree of autonomy and decision-making responsibility throughout the post-approval lifecycle, including new product registrations, CMC regulatory strategy, MAH obligations, and regulatory submissions across the UK and EU.
Key Responsibilities:
- Own regulatory strategy and submissions across the product portfolio
- Manage post-approval lifecycle activities, including variations, renewals and line extensions
- Oversee MAH and PV compliance, including PSMF/QPPV arrangements, safety reporting and RMP commitments
- Lead regulatory strategy for new Marketing Authorisation applications and line extensions
- Define regulatory pathways across UK and EU markets
- Plan and oversee dossier preparation, submission and health authority interactions
- Review and approve CMC regulatory content, including manufacturing changes and comparability considerations
- Oversee packaging, labelling and artwork updates
- Manage external regulatory consultants, contractors and specialist partners
- Lead and develop the regulatory team while ensuring high-quality, compliant submissions
- Manage the regulatory budget, forecasting and external spend
About You:
- Strong experience in pharmaceutical Regulatory Affairs with proven ownership of regulatory activities across a portfolio of medicinal products
- Demonstrable experience with variations, renewals and new Marketing Authorisation applications
- Experience with dossier planning, submission management, LoQ responses and health authority engagement
- Strong CMC regulatory experience, including manufacturing changes and comparability considerations
- Experience with MAH responsibilities and a good understanding of PV, PSMF and QPPV requirements
- Experience managing internal teams, external consultants or regulatory partners
- Experience managing regulatory budgets and external regulatory spend
- Good knowledge of UK and EU regulatory frameworks
- Experience working in a small or mid-sized pharmaceutical environment is highly desirable
- Able to operate independently, make strategic regulatory decisions and take ownership of complex regulatory matters
- Comfortable working in a hybrid environment with 3 days per week in the office
Associate Director Regulatory Affairs in Slough employer: Walker Cole International
Walker Cole International is an exceptional employer that prioritises a dynamic and patient-focused work culture, making it an ideal place for professionals in Regulatory Affairs. With a commitment to employee growth and development, the company offers unique opportunities to engage with international markets while ensuring compliance and driving product lifecycle management. Located in a vibrant industry hub, employees benefit from collaborative teamwork and the chance to make a meaningful impact in the pharmaceutical sector.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director Regulatory Affairs in Slough
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Walker Cole International. 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 Walker Cole International.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Walker Cole International. 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 Walker Cole International 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 Slough
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 Walker Cole International!
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 Walker Cole International 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 Walker Cole International!
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 Walker Cole International, 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 Walker Cole International
✨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 Walker Cole International 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 Walker Cole International’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.
