Responsible for providing global strategy and labelling leadership for development assets and oversight for established products.
Drives optimal regulatory labelling outcomes for development assets across development and life cycle management to deliver technical excellence enabling R&D and commercial success.
- Acts as Subject Matter Expert on local and international regulatory labelling requirements, providing the regulatory labelling recommendations globally to senior managers and governance committees.
- Leadership of the Global Labelling Committee.
- Development of key labelling concept and CCDS (creation of the initial CCDS for the development product) together with R&D, Market Access and commercial colleagues.
- Drives optimal product labelling approaches that facilitate the safe and accurate use of Mundipharma’s products and enables product/portfolio differentiation and competitiveness.
- Ensure ongoing compliance of established products in the life cycle process via our outsourcing partners.
- Leads initiatives within regulatory and in partnership with other functions (artwork, IACs, drug safety etc) to improve labelling process and compliance.
- Provide overall strategic labelling expertise and leadership across all products.
- Works with regulatory leads and wider teams to define strategies to gain optimised labelling for development products.
- Engage with regulatory leads to input the labelling viewpoint into effective agency negotiations and interactions.
- Strategically direct outsourcing partners to ensure effective delivery of labelling support for our established product that is fit for purpose and aligned with objectives.
- Undertake labelling Due Diligence review support where required.
KEY SKILLS & EXPERIENCE
- Ability to work within the regulatory team and wider asset teams to influence and advise on labelling strategy and issues.
- A global mindset that seeks alignment across regions with a pragmatic approach.
- Comprehensive knowledge of relevant legislation and guidelines and ability to communicate these concepts across multiple levels of the organisation.
- Willingness to take ownership and drive through change and strategies.