Regulatory Affairs Manager
4 days left
- Experience Level
Job Title: Regulatory Affairs Manager - Regulatory Portfolio Lead
Location: Remote in the UK or Office based in Central London
Salary: Basic salary up to £60k (with some flexibility) + Bonus, pension etc.
As a world leader within the Consumer Healthcare space, this company has created some of the most recognisable brands in the world in various categories including pain management, Cough & Cold, Oral care, weight loss and health supplements. They are a large, international company in a strong financial position, meaning that there is certainly a strong element of stability whilst also having the benefit of working in an agile, fast paced affiliate.
Reporting into the Head of Regulatory Affairs, you will be responsible for all of the Regulatory activity within your assigned portfolio and will be the Regulatory Portfolio lead. We are currently looking for 2 x Regulatory Project Managers/Regulatory Portfolio leads and each will have full accountability within their portfolio. You will both line manage and project manage regulatory teams to achieve successful product approvals, license maintenance, new claims development etc. A big part of the role will be to work as a partner to the commercial teams, working together to develop artwork, packaging and claims materials that are compliant to UK regulations. This is a great opportunity for any commercially astute Regulatory professionals who would enjoy working closely with commercial functions as a partner.
One important point to make is that in this business, regulatory is genuinely seen as an enabler and business partner, rather than what is often the case of RA being seen as a roadblock by other functions. This allows for true partnership and meaningful collaboration between RA and the other functions across the business.
In short, you'll have accountability for all RA activity within your portfolio including new MAA, site transfer, maintenance activities, new claims development, marketing materials etc. along with the people management that goes with those projects.
Your main duties and responsibilities also include:
- Lead regulatory activities for assigned portfolio (e.g.: new MAA, post MAA activity) providing updates to business and reporting against project plans
- Support brand management, including product name strategy, product information text, commercial activity (review of claims and advertising material) and pack design (artwork management
- Develop regulatory strategies for new MAAs and product lifecycle maintenance activities, identifying risks and opportunities
- Manage, execute and coordinate new MAA applications and support product lifecycle maintenance activities (including variations, renewals and safety updates).
- Develop, roll out and maintain relevant internal procedures and best practices.
- Ensure compliance of commercial activity and portfolio
- Maintain the integrity of regulatory data in the relevant databases
- Support more junior members of the team and help with their personal development
For more information please reach out to Chris Gibson, Head of Life Sciences at Usurpo - email@example.com or 07508061234
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