Regulatory Affairs Manager

**MAIN PURPOSE**:
The Regulatory Affairs Manager is responsible for the lifecycle management of key Norgine Product post EU approval, ensuring smooth integration of new products following launch and all associated on-going regulatory maintenance activities, this includes:

- Regulatory Impact Assessment of proposed changes and robust strategies for implementation
- Engaging and proactively communicating with key internal stakeholders and the Regulatory Authorities to deliver against objectives set by the business
- Ensuring submissions made are of high quality, in compliance with regulatory requirements, submitted and approved timely in accordance with business need
- Support inspections and audits, as applicable
- Proactively contribute to the maintenance of robust procedures as applicable
- Supervise more junior staff in relevant tasks, processes and activities as applicable
- Maintain up to date knowledge of relevant regulations and guidelines, and propose strategies for effective implementation, knowledge sharing and advice to project teams
- Implement agreed regulatory strategies to plan, anticipate and resolve roadblocks, escalate issues through effective communication
- Proactively communicate with relevant internal stakeholders and external contacts, e.g. partners, and induce a trustful working relationship to ensure regulatory requirements for submissions are met and approvals expedited
- Proactively communicate with regulatory authorities in order to negotiate solutions on issues and request for information, and expedite approval of submissions
- Ensure preparation, submission, approval and maintenance of high quality documentation, following current best practice standards
- Provide expert advice and support to brand teams and other areas of the business
- Provide input into the budgeting process e.g. relating to regulatory fees and CRO support required for prospective regulatory submissions
- Manage own workload to ensure agreed regulatory timeframes are met, and propose solutions to own manager if resource constraints
- Explore opportunities for continuous improvement to enhance business performance
- Manage, coach and mentor peers and direct reports, if applicable, to deliver Norgine business objectives, ensuring their continued personal development
- Maintain data and documentation in compliance with Norgine’s regulatory systems and procedures
- Interact with industry trade associations and external consultants as necessary
- Considerable regulatory experience with EU regulatory requirements and processes (MRP, DCP and CP) for LCM activities
- Considerable regulatory experience with AU and NZ MAA and LCM regulatory requirements and processes
- Effective negotiation and influencing skills
- Proven ability to manage multiple projects efficiently
- Ability to analyse and interpret complex issues, and develop and communicate strategies and plans to resolve
- Clear communicator, sharing information to ensure successful partnering with internal and external stakeholders. Listens and responds effectively to others
- Responds quickly and positively to customer needs, develops effective collaborative working relationships with customers/external partners
- Shows strong respect and collaborative working with internal and external customers
- Aspires to continuously develop technical/professional knowledge and interpersonal/management expertise to be a good role model.
- Displays commitment and takes responsibility for personal performance and self-development
- Displays integrity, discretion and confidentiality when communicating with others, exhibits sound judgement
- Seeks and accepts responsibility to enhance overall business performance
- Focusses on improving efficiency to ensure cost effective utilisation of both internal and external resources, maintains a flexible and constructive outlook
- Able to contribute to budget preparation and review

Further responsibilities
- Co-ordinate QMS related regulatory activities e.g. CAPA’s as applicable, to ensure compliance with actions.

**DUTIES & RESPONSIBILITIES**:
**INDIVIDUAL REQUIREMENTS**:
**Qualifications**

**Competencies