SRG are currently looking for Regulatory Senior Executive for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team to be...
My client, a Global Pharmaceutical Company, has opened a new vacancy within their Regulatory team and are actively looking to recruit a Senior Regulatory Labelling Manager. The role will be based at my client's offices in Central London.
The Global Labelling Team at is seeking an experienced and highly motivated Labelling Lead with specialisation in Global Labelling who has a comprehensive understanding of strategic labelling and enjoys a fast-paced and dynamic work-environment. They will have a proven ability to develop strong matrix working relationships, and will be responsible for collaborating across the global regulatory affairs department and with cross-functional experts to implement labelling strategies for marketed and development products.
- Management of Global labelling including the development, review and internal approval from early development through to life-cycle management.
- Represent Global Labelling Team at product-specific global regulatory teams, labelling working groups and labelling governance committee meetings.
- Acting as a subject matter expert to provide strategic labelling advice for ROW regional labels, providing strong guidance on country-specific labelling regulations and guidelines as it pertains to health care provider and patient information, packaging and artwork, competitor labelling, and labelling trends.
- Providing strategic and tactical labelling advice and guidance to cross-functional teams.
- Inputting into responses to labelling-related Health Authority queries.
Skills and Experience required:
- BSc. Advanced scientific related degree preferred;
- Extensive hands on experience within Regulatory Labelling
- A demonstrated through knowledge of labelling regulations and guidance's governing drug development and maintenance in Rest of World markets (ex US, Ex EU) with a good understanding of major markets requirements (EU, US and Canada etc).
- A demonstrated understanding of the development and life-cycle management of global labelling, from Target Labelling Profile to Company Core Data Sheet.
- Proven ability to independently direct the activities of cross-functional teams, with ability to lead and influence others and to collaborate effectively with peers, within global teams and in communicating with senior leadership.
- Ability to effectively present information to senior management and to cross-functional teams.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Neal.Panting@SRG.co.uk or +441753 589626