Beschreibung
Senior Manager Regulatory Affairs (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Responsible for defining Biosimilar regulatory strategies for assigned projects and programs and for obtaining project team alignment on those strategie
- Regulatory representative with strategic partner(s) for assigned projects and programmes and responsible for securing partner alignment on regulatory strategy
- Responsible for implementing defined regulatory strategies, including filing of all appropriate regulatory submissions for assigned projects and programs.
- Responsible for leading the co-ordination of all aspects of regulatory submissions relevant to assigned projects or programs
- Responsible for the development of core aRMMs and for leading their customisation, submission, approval and dissemination across markets. Responsible for the implementation of updates to approved aRMMs
- Define Biosimilar labelling strategy, taking into account commercial and medical drivers. Align with strategic partner on labelling strategies. Manage the implementation with cross functional teams and local regulatory to ensure successful execution
- Discuss and align regulatory CMC strategies internally and facilitate alignment as needed.
- Provide regulatory support and guidance to supply & planning, quality, manufacturing, logistics functions as needed
- Manage regulatory review of promotional materials, sales training materials and other external communications, negotiating regulatory compliance within established risk parameters including building business processes where necessary to train and audit affiliates and distributor teams and to approve pan-EU promotional materials
- Develop regulatory strategies to support the lifecycle management of products in line with business requirements
Main qualifications
- Experience in the pharmaceutical/biotechnology industry with at least experience in regulatory affairs
- Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements
- Good knowledge of applicable regulations, regulatory guidelines and submission requirements and ability to interpret regulations and guidelines
- Foster effective, positive interactions with regulatory agencies, and corporate partners
- Some experience interfacing with relevant regulatory authorities
- Ability to represent the department in project teams, committees and external meetings to attain group goals
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Strong sensitivity for a multicultural/multinational environment and experience leading multi- disciplinary teams
Main advantages:
- Responsible for leading regional regulatory affairs activities for assigned projects and programs
- Responsible for defining strategies for meeting and keeping post approval compliance.
About us:
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
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