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Archiviertes Projekt - Regulatory Affairs Manager (m/f/d)

Firmenname für PREMIUM-Mitglieder sichtbar

Dezember 2020

nicht angegeben


auf Anfrage




Ihre Aufgaben:
• Leads the regulatory working team for EUCAN region and represents region as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan
• Collaborates to define, develop and lead EUCAN strategies to maximize regulatory success towards achievement of program objectives and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
• Manages, plans and executes the preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program.
• Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database.
• Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs.
• Stays current with regulations & guidances in EUCAN for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance.
• Provides regulatory expertise for multiple projects including one highly complex program, focused on non-clinical and clinical aspects of registration and / or post-marketing compliance and life cycle management.
• Develops effective working relationships with EUCAN GI&NS Team members, LOC RA teams, Global Regulatory Teams, Cross-functional Teams; consultants and business partners.
• In close collaboration with local regulatory lead when applicable, provides strategic guidance / advice on emerging regional trends, regulations and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs.
• Supports preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required
• Represents Emerging Markets in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps, as required
• Leads and manages meetings with regional and local regulatory authorities and is aware of relevant regulatory agency meetings scheduled with other regions (such as FDA).
• May be called upon to support in due diligence for licensing opportunities, development and /or marketed product opportunities.
• Identifies and proposes solutions to the management of resource gaps for areas of responsibility

Ihre Qualifikationen:
• BS degree or equivalent in science; advanced degree preferred
• Sound experience within the pharmaceutical industry, including direct experience in regulatory affairs in post-marketing phases and development.
• Profound directly related regulatory experience is desirable.
• Working knowledge of regulations and guidances governing drugs and biologics in development, including post-marketing in EU, including interactions with Health Authorities. A good understanding of basic regulatory requirements in emerging markets is a plus. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
• Generally strong in most and acceptable in all basic skill sets, such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Understands and interprets complex scientific issues and capability to relate to regulatory requirements and strategy.
• Able to demonstrate skill(s) 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 and within global teams.
• Experience managing relationships with CROs and/or contractors preferred.Passionate and self-confident

Ihre Vorteile:
• Reputable / modern company

Projektdauer: 9 MM+

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