* Oversee and take ownership for Regulatory activities and strategies for assigned projects and preparation and submission of new UK and IE Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products
* Ensure high quality data and standards are used in support of all regulatory applications
* Full lifecycle management of product allocation, including support of new product launch activities for both UK and IE
* Work proactively with internal and external stakeholders (e.g. MHRA and HPRA) to ensure work is prioritised in accordance with business needs
* Mentoring and training of other regulatory professionals as required
Main Accountabilities:
* Responsibility/ownership of UK/IE assigned Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products
* Deliver new submission work plan commitments for all allocated products.
* Ensure that regulatory approvals are secured in a timely manner for on-time launches.
* Ensure that regulatory post approval obligations are fulfilled to ensure compliance, deliver on-time launches and maintain continuity of supply.
* Provide/contribute to regulatory strategies, guidance and support for product development to approval for local co-development initiatives and local in-license of new products
* Resolve complex problems or problems where precedent may not exist
* Provide regulatory guidance to cross-functional teams within the organization.
* Ensure that responses are submitted on time and that content is aligned with MHRA/HPRA data requirements.
* Actively participate in preparations for health authority meetings and effectively lead discussions. Contribute to industry association projects and participate in regulatory professional body activities on request.
* Maintain an in-depth understanding of legislative requirements, MHRA regulatory guidance and changes to the external environment that could affect the UK/IE market.
* Other duties as required by the direction of the Senior Manager and/or business needs.
* Work with a broad range of internal and external customers across complex projects.
* Manage change in a very dynamic fast-paced environment.
Decision Making:
* Organisation of workload to meet departmental and Company targets
* Acceptance of data and documentation for use in registration submissions
* Management of own projects
* Regulatory strategy for new marketing authorisations and post-approval changes ensuring regulatory compliance
Relationships:
Internal:
* All personnel within UK/IE and EU regulatory Affairs
* EU Regulatory Affairs UK/IE Medical director
* UK/IE commercial, portfolio and project teams
* UK/IE supply chain teams
* UK/IE PV teams
* UK/IE commercial quality teams
* Artwork Origination
* Legal
* RA CMC / R&D teams
External:
* MHRA
* HPRA
Qualifications:
* Pharmacy/Chemistry or Life Sciences degree
Experience:
* Experience in regulatory affairs in pharmaceuticals
* Demonstrated experience of contact, relationship and working with MHRA and HPRA.
* Substantial regulatory new submission and post approval submissions experience for a wide range of dosage forms including generics, new chemical entities, devices and OTC products.
* A working knowledge and experience in CTAs, paediatric investigation plans and orphan designations.
* Regulatory strategy development with a focus on bringing innovative solutions to project teams and health authorities.
* Risk assessment and project management skills.
Knowledge:
* Detailed knowledge of CMC supporting data requirements for new Marketing Authorisations for generic/hybrid and new chemical entities
* In-depth knowledge of different dosage types and submission routes
* Detailed knowledge of clinical data requirements for new Marketing Authorisations for generic/hybrid and new chemical entities
* Detailed knowledge in registering medical devices
* Detailed knowledge of the full lifecycle management of pharmaceutical products
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