To apply for this regulatory affairs manager role please call Julie Cooper on 020 8305 9733 or 07951 082482
Alternatively please send your CV to:
- Supports the implementation of regulatory operational activities in the UK/Ireland, and provides regulatory support to the registration and post-licensing of EU medicinal products in the UK/Ireland region.
- Is responsible for the maintenance of regulatory packaging, tracking systems and regulatory knowledge databases for the UK/Ireland.
2) EU Product Lifecycle Management
- Supports the implementation of regulatory strategy in Europe and the EEA and provides regulatory support for the registration and post-licensing activities of medicinal products.
- Develops and maintains knowledge of EU regulatory procedures .
- Builds and maintains relationships with Regulatory and other staff within and outside the region to ensure effective communication and efficient implementation of regulatory activities.
KEY DUTIES AND RESPONSIBILITIES
1.1. UK/Ireland Regulatory Affairs 40%
- Reviews and approves product-related packaging and other materials, as required and in accordance with company metrics/agency deadlines e.g. Braille, Patient Information Leaflet User Testing, etc., ensuring regulatory compliance. Liaises with EU RA, the Packaging Co-ordination group (PCEAM) and logistics to ensure that any labelling changes are planned and implemented in line with company and agency expectations.
- Plans and implements regulatory activities in support of lifecycle management (renewals and variations) in the UK/Ireland.
- Establishes relationships with EU regulatory teams thereby ensuring local RA activities are in line with global and regional business priorities.
1.2. Product Lifecycle Management 20%
- Plans and implements regulatory activities in support of lifecycle management (renewals) and CMC maintenance in the region.
- Ensures effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.
- Ensures effective handover from development team.
- Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during lifecycle management and maintenance.
- Together with the regulatory staff “in country”, develops an awareness of key individuals within the Regulatory Agencies, to ensure a clear understanding of requirements and effective representation of Allergan.
- Establishes relationships with “in country” teams and global regulatory teams thereby ensuring local RA activities are in line with global and regional business priorities.
- Manages marketed product labelling, to ensure alignment with Core Data Sheets and compliance with legal/regulatory requirements,
- Implements CMC changes in line with agreed company change control and global CMC plans
- For Centrally approved products, co-ordinates activities (e.g. implementation of labelling, educational materials, etc) post EC decision, to ensure effective regulatory support for product. For MRP/DCP approved products co-ordinates activities (e.g. implementation of national phase, translations, educational materials, etc) post Positive Opinion, to ensure effective regulatory support for product.
- EU RA ownership for Development projects where there is no formal development project team
- Manages post-approval work not requiring a global project team including Post -approval Safety and Efficacy Studies, and other follow up measures.
- Act as Commercial liaison for PLM activities in the UK/Ireland
3. Compliance Activities 20%
- Ensures that local processes are reviewed and updated regularly and are aligned with global/regional policies and processes and local requirements.
- Maintains a state of inspection readiness
- Assists in the compilation or retrieval of any requested documentation prior to or during an inspection
- Represents the Company in inspection interviews relating to individual case handling
3. Business Support 15%
- Provides the EU and UK/Ireland Commercial Units with clear constructive regulatory advice and intelligence to maximise opportunities and counter threats to the business.
- Defines regulatory requirements, develops and subsequently implements, plans in support of regional and local business initiatives.
- Represent EU Regulatory on UK Management Team
4. Processes and organisational effectiveness 5%
- Provides input into development of processes to leverage global processes and infrastructure and maximise efficiency and effectiveness
- Provide input into critical metrics and management reports
- Take personal responsibility for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects.
- Maintains a performance and improvement culture
Desired Skills & Experience
Education and Experience
- Life Sciences Graduate, ideally with post-graduate qualification in a relevant area and/or prior experience in product development functions (pharmaceutical development, toxicology, clinical trials, etc).
- Good knowledge of both national regulations within the UK/Ireland region and European pharmaceutical regulations and guidelines.
- Regulatory Affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within UK/Ireland and/or Europe.
- Experience in cross-functional project teams.
- Conversant with the primary functions of pharmaceutical development, microbiology, toxicology, clinical research and quality assurance.
Essential Skills and Abilities
- Organisational and planning ability
- Negotiation skills
- Excellent communication skills, both written and verbal (in English).
- Ability to work effectively and collaboratively across cultures and cross-functionally.
- Computer literate.
Company is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 10,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
Key words / key word:
regulatory affairs manager , reg affairs manager , regulatory affairs , UK , Product Development , Bucks
- 9 months ago