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- Tasks: Lead regulatory labeling strategy and manage projects for pharmaceutical clients.
- Company: Opus Regulatory, a niche firm with a focus on Regulatory Affairs consulting.
- Benefits: Competitive salary, professional development, and opportunities to work with industry leaders.
- Why this job: Make a real impact in the biopharmaceutical industry while driving innovative labeling strategies.
- Qualifications: 4+ years in regulatory affairs with a focus on labeling strategy; advanced degree preferred.
- Other info: Dynamic role with opportunities for global experience and career advancement.
The predicted salary is between 60000 - 84000 £ per year.
About Opus Regulatory, Inc. Founded in 1994, Opus Regulatory (Opus) is a niche firm providing experts in Regulatory Strategy, CMC, Labeling, Ad Promo and Medical Review. Our clients range from development stage biotech companies to mid-size and large pharmaceutical companies. Our team is made up of biopharmaceutical leaders and innovators, and our mission is to provide the highest-level Regulatory Affairs consulting service in the industry and to continually exceed the expectations of our clients.
The Principal Consultant, Regulatory Affairs Labeling Strategy (Manager to Senior Director levels) is primarily responsible for the daily management of regulatory requirements for labeling strategy or labeling operations for one or more projects, designing and implementing labeling strategy, providing leadership to drive labeling consensus, and developing relationships with client subject matter experts and regulatory authorities. We have a robust client portfolio offering a variety of projects across therapeutic areas and regions.
Responsibilities include:
- Labeling experience across Development, Core, US, EU and Rest of World (ROW) Labeling.
- Understanding of end-to-end labeling process and systems.
- Lead preparation, review, and update content for the development and maintenance of Target Product Label (TPL), Company Core Data Sheet (CCDS), and local labeling and labeling components.
- Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory labeling, process, filing, best practices, etc. in conjunction with client leadership.
- Provide support and guidance to regulatory teams on RA requirements for one or more drug products by evaluating and communicating risks associated with CCDS content updates and implementation strategies.
- Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
- Develop and drive regulatory labeling timelines and deliverables.
- Understanding of labeling governance and process work.
- Support agency requests and documentation process for impact to labeling; participate in agency meetings as requested.
- Maintain knowledge of changing regulatory requirements and advise teams as appropriate.
- Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.
Qualifications:
- Must have a minimum of 4 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy.
- Bachelor’s degree required; Advanced degree in a science discipline preferred.
- Experience across multiple therapeutic areas is highly desirable.
- Demonstrated global and international experience is required.
- Proven project management skills to support the planning and coordination of labeling submissions and support appropriate regulatory inspections.
- Ability to work independently and innovatively in tackling operational challenges.
Principal Consultant Regulatory Affairs, Labeling Strategy - UK employer: Opus Regulatory Inc.
Contact Detail:
Opus Regulatory Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Consultant Regulatory Affairs, Labeling Strategy - UK
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or at events. We can’t stress enough how important it is to build relationships; you never know who might have the inside scoop on job openings.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. We recommend practising common interview questions and tailoring your answers to highlight your relevant experience in regulatory affairs and labeling strategy.
✨Tip Number 3
Showcase your expertise! Bring examples of your past work, especially any successful labeling strategies you've implemented. We love seeing candidates who can demonstrate their impact in previous roles.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who want to make a difference in regulatory affairs.
We think you need these skills to ace Principal Consultant Regulatory Affairs, Labeling Strategy - UK
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Principal Consultant role. Highlight your experience in regulatory affairs and labeling strategy, and don’t forget to mention any relevant projects you've worked on. We want to see how your background aligns with what we do!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your skills can benefit our team. Be sure to mention specific experiences that relate to the job description – we love a good story!
Showcase Your Expertise: In your application, make sure to showcase your knowledge of US, EU, and ICH regulatory requirements. We’re looking for someone who can hit the ground running, so let us know how you’ve applied this knowledge in past roles.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get the best experience possible. Plus, it shows you’re keen on joining our team at Opus Regulatory!
How to prepare for a job interview at Opus Regulatory Inc.
✨Know Your Labeling Strategy Inside Out
Make sure you have a solid understanding of the end-to-end labeling process and systems. Brush up on your knowledge of US, EU, and ICH regulatory requirements, as well as the specifics of Target Product Labels (TPL) and Company Core Data Sheets (CCDS). This will help you demonstrate your expertise and show that you're ready to hit the ground running.
✨Showcase Your Project Management Skills
Be prepared to discuss your project management experience in detail. Think of specific examples where you've successfully coordinated labeling submissions or managed timelines. Highlight how you tackled operational challenges and what strategies you used to ensure compliance with regulatory requirements.
✨Build Rapport with Regulatory Authorities
Since you'll be working closely with client subject matter experts and regulatory authorities, it's crucial to convey your ability to build strong relationships. Share examples of how you've effectively communicated with these stakeholders in the past and how you can facilitate consensus within a team.
✨Stay Updated on Regulatory Changes
Demonstrate your commitment to staying informed about changing regulatory requirements. Discuss any recent updates you've followed and how they might impact labeling strategy. This shows that you're proactive and dedicated to providing the highest-level consulting service, which aligns perfectly with Opus Regulatory's mission.