Regulatory Affairs Manager (m/f/d)

Firmenname für PREMIUM-Mitglieder sichtbar

  • Januar 2023
  • nicht angegeben
  • CH-Zürich
  • auf Anfrage
  • 03.01.2023
  • 666698/1-en

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Ihre Aufgaben:
• Ensures regional regulatory strategies are written, reviewed and executed according to plan
• In alignment with line manager, provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
• Manages, plans, and executes regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle
• Partners with the regional market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making
• Identifies relevant regional regulatory requirements and trends across scope of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
• Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to area and region of responsibility May be called upon to provide direction to senior leadership, as relevant
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
• Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed
• In collaboration with global colleagues, works to resolve regional critical conflicts in global regulatory strategies. Authors and oversees execution for more complex regional regulatory strategies as needed
• Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or higher governance bodies in these areas

Ihre Qualifikationen:
• BSc. Advanced scientific related degree preferred; BA accepted based on experience, advanced degree preferred
• Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases
• Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU
• Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy
• Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in either EU or US region (as relevant to role) with global involvement also preferred
• Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
• Able to train/develop junior colleagues in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally
• Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
• Generally strong in working well with others, within global teams and communicating with senior leadership
• Experience managing relationships with CROs and/or contractors also preferred

Ihre Vorteile:
• International pharma company
• Remote possible

Projektdauer: 5 MM++

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