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: Hybrid work environment with a focus on collaboration and innovation.
- Why this job: Make a real impact in the pharmaceutical industry while developing your career.
- Qualifications: Strong experience in regulatory affairs and proven leadership skills.
The predicted salary is between 63000 - 77000 £ 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 Planning Director - Contract in City of London 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 Planning Director - Contract in City of London
✨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 Walker Cole International.
We think you need these skills to ace Associate Planning Director - Contract in City of London
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 Walker Cole International.
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 Walker Cole International. 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 Walker Cole International
✨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 Walker Cole International.
✨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 Walker Cole International 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.
