Regulatory Affairs Development Manager

- Mendrisiotto(Ticino) - Svizzera

  • Informazioni generiche

    Contratto a tempo indeterminato. Occupazione al 100%.



  • We are seeking a Regulatory Affairs Development Manager for our client, a very important international industry based in the beautiful Mendrisiotto area.  

    POSITION SUMMARY
    The company is facing a huge transformation which impacts its structure, strategies, culture, policies, and technology. The new Company policy will bring to embrace new business opportunities. New policy of product acquisition, aimed to widen the Company portfolio, implies the creation of a Task force engaged in due diligence to evaluate regulatory risks and opportunities in the concerned worldwide markets. This new direction together with the increasing number of registration applications triggers for a re-design of the Regulatory Affairs department to bring in highly experienced people with new competencies and talents to manage increased complexity of projects and to deliver successful results, contributing effectively to the Company growth.
    The candidate will report directly to the Corporate Regulatory Affairs Manager and supervise and mentor the Regulatory Team. He/She will also collaborate with the various internal functions external stakeholders (CMOs, commercial partners, etc.).

    TASKS AND RESPONSIBILITIES
    • Establishing a strategy from development to registration and supporting the execution (directly and/or through supervising the operational resources) of the global regulatory affairs lifecycle and manage approved registrations through collaborating with the various internal and external stakeholders (CMOs, commercial partners, etc.).
    • Overseeing development projects and performing Due Diligence activities to evaluate regulatory risks and opportunities.
    • Identifying in advance potential hurdles that might impact the regulatory success of development activities and/or potential licensing in processes.
    • Supporting the Regulatory Corporate Manager in IND, NDA, and ANDA strategy preparation, involving and training the RA Team members responsible for operational activities.
    • Providing operational support with strategic regulatory documents to help drive timely deliverables.
    • Coordinating and driving team meetings to ensure quality and timely responses to health authority queries.
    • Securing global submission plans together with the main area Project Manager and ensuring these plans can be executed on time.
    • Supervising the marketing application submission team (EU/CH/US and RoW), helping to develop strategy and content for global dossiers.
    • Translating regulatory requirements into practical workable submission plans.
    • Supervising the resources currently managing patents and trademarks by navigating the relevant multiple legal domains in pharmaceutical research, development, and innovation.
    • Remaining constantly updated on regulations and sharing knowledge within the RA team members to promote their growth.

    KNOWLEDGE AND SKILLS
    • At least 4-5 years' regulatory affairs experience
    • Deep knowledge of pharmaceutical legislation and regulations
    • Experience in EU registration procedures (MRP/DCP MAA, post approval changes, extensions, and renewals).
    • Preferably previous experience with global registrations
    • Preferably CMC (quality part of the dossier) knowledge
    • Very good English and Italian communication and writing skills (knowledge of French or German would be an asset)
    • Organizational skills and regulatory project management skills
    • Ability to resolve conflicts and develop a course of action leading to beneficial outcomes
    • Cultural awareness and sensitivity to achieve results across regional, national, and international borders
    • Commitment to continuous improvement
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