Regulatory Affairs Manager UK&IRE

Skills Alliance Limited
London (Greater)
10 Feb 2018
15 Feb 2018
Contract Type
Full Time
Title: Regulatory Affairs Manager

Reports to: Regulatory Affairs Lead

Type: 12 Month Contract


- Deliver and maintain competitive licences for UK/Ireland/Malta including driving regulatory strategy for new initiatives. Ensuring regulatory compliance for defined product and project responsibilities, including project leadership.
- Timely delivery of clinical trial approvals and maintenance of high regulatory compliance standards for UK/Ireland/Malta achieved through provision of local regulatory expertise.
- Support the development of AZ investigational and in-licensed/ co-development products through valued contributions to MC3 projects, study feasibility questionnaires, scientific advice meetings and other related activities.
- Full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and Standards.

Generate Competitive Licences (0-40%)

- Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling
- Develop professional working relationships with assessors and administrative staff within the regulatory agencies
- Prepare high quality regulatory applications and regulatory responses for UK/Ireland/Malta (including inputting into summary documents and responses for European applications)
- Defend existing labelling and provide regulatory input into patent defence strategies
- Filings/approvals on or before schedule with competitive labels
- Evidence of increased access and influence
- Regulatory metrics

Regulatory Compliance & Governance (0-10%)

- Ensure timely submission and approvals of licence applications and maintenance activities and compliance with UK/Ireland/Malta regulatory requirements
- Assure appropriate standards and policies for all technical aspects of the company's activities in Regulatory Affairs are adhered to
- Provide regulatory input/solutions to supply and stock issues
- Liaise with Operations to manage pack changes and ensure labelling compliance
- Submissions and approvals are delivered to target
- Training records are up to date
- No UK regulatory attributed delays or rejections
- No UK Regulatory attributed MQIs leading to market action
- Regulatory metrics

Commercial Support (0-15%)

- Actively contribute to cross-functional team working within the Medical & Healthcare Directorate and other areas of the business
- Deliver the commercial objectives, including representing Regulatory Affairs on teams as appropriate
- Ensure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence
- Provide strategic regulatory input relating to AZ promoted and cornerstone brands, including competitor intelligence
- Provide strategic regulatory advice relating to environmental 'shift' (e.g. POM-P, duplicates, own label supplies, generics, management of black triangle/ symbol)
- Project manage and deliver projects of commercial strategic value
- Feedback from cross functional teams
- Evidence of RA value

Formulate and Influence Regulatory Strategy (0-15%)

- Ensure focused regulatory input into new product development via MC3 etc. in the UK/EU business interest
- Understand and promote UK/Irish business needs into European strategies on drug development and regulatory filings/issues
- Ensure appropriate cross functional input into the delivery of optimal licence strategies
- Proactively identify regulatory strategies to support commercial and business objectives and company efficiencies.
- Feedback from cross functional teams

Clinical Support (0-10%)

- Proactively manage the regulatory process for clinical trials for UK, Ireland and Malta
- CTAs and DSURs kept in compliance
- Approvals delivered to target, no studies held up due to regulatory submission delays

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