Senior Manager Global Regulatory Labelling

Job Ref: J31898
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Permanent
Date Added: 15 May 2019
  • City of London, London, England, UK City of London London UK WC1 1AA
  • Competitive
    ANNUM
  • Neal Panting
  • 01753 589601
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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 Role:

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.

Key Responsibilities:

  • 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

SRG
14/06/2019 15:47:58
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