Regulatory Affairs Manager

vor 1 Woche

Wien, Wien, Österreich Norgine Vollzeit

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 selfdevelopment
  • 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

  • Coordinate QMS related regulatory activities e.g. CAPA's as applicable, to ensure compliance with actions.

DUTIES & RESPONSIBILITIES:

INDIVIDUAL REQUIREMENTS:

Qualifications
**Competencies

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