At a Glance
- Tasks: Lead complex regulatory submission projects and ensure high-quality dossiers are delivered on time.
- Company: Join a leading pharmaceutical company with a dynamic regulatory affairs team.
- Benefits: Competitive pay, hybrid working options, and potential for contract extension.
- Other info: Great opportunity for career growth and to enhance your project management skills.
- Why this job: Make a real impact in healthcare by supporting innovative product approvals.
- Qualifications: Bachelor's degree and experience in regulated industries required.
Contract: Temporary - 12 months (extension possible)
Location: Maidenhead - hybrid working (or remote if needed)
Rate: (INSIDE IR35) - circa. £22-25 per hour (PAYE)*
SRG are seeking a Regulatory Affairs professional with Submission Management skills & experience to assist a leading pharmaceutical company on a temporary basis. Join a dynamic regulatory affairs team and play a pivotal role in delivering complex regulatory submissions that support the development, approval, and life-cycle management of innovative healthcare products.
Key Responsibilities
- Lead and manage complex regulatory submission projects, ensuring high-quality dossiers are delivered on time and in line with regulatory requirements.
- Act as the primary regulatory submission management contact for cross-functional project teams, providing guidance on processes, timelines, and deliverables.
- Coordinate and facilitate submission planning meetings, driving progress across multiple concurrent projects and stakeholders.
- Oversee publishing activities and collaborate with external publishing partners to ensure successful submission delivery.
- Perform quality reviews of published submissions, ensuring compliance with technical standards and regulatory authority requirements.
- Contribute to continuous improvement initiatives, enhancing regulatory processes, standards, and systems.
Skills & Experience Required
- Bachelor's degree or equivalent combination of education and relevant industry experience.
- Experience within the pharmaceutical, biotechnology, healthcare, or related regulated industry.
- Strong project management skills, with experience managing complex, cross-functional activities and competing priorities.
- Knowledge of regulatory operations, submission management, and/or submission publishing processes.
- Excellent written and verbal communication skills, with the ability to influence stakeholders in a matrix environment.
- Demonstrated leadership capability, including mentoring colleagues and driving process improvements.
- PMP and/or RAC certification is advantageous.
To Apply: Please click and submit your profile and/or to discuss further, contact Theo Charles.
Manager, Regulatory Affairs Submission Management in Maidenhead employer: Carbon 60
At Carbon 60, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to thrive. Located in Harlow, this hybrid role offers flexibility and the chance to engage with a dedicated Quality team, ensuring your contributions directly impact our commitment to quality excellence. With opportunities for professional growth and development, joining us means being part of a forward-thinking company that values your expertise and dedication.
StudySmarter Expert Advice🤫
We think this is how you could land Manager, Regulatory Affairs Submission Management in Maidenhead
✨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 Carbon 60.
We think you need these skills to ace Manager, Regulatory Affairs Submission Management in Maidenhead
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 Carbon 60.
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 Carbon 60. 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 Carbon 60
✨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 Carbon 60.
✨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 Carbon 60 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.
