Your responsibilities
- Accountable for supporting initial and post approval submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets
- Ensure transparency and excellence in evaluation, definition and execution of regulatory strategies
- Manage initial and post approval strategy (including timelines) and execution in alignment and partnership with key stakeholders to ensure a submission ready dossier
- Ensure dossiers are produced and dispatched to assigned markets according to their defined filing plan, and are submission ready
- Communicate changes to regulatory requirements and update the appropriate system in a timely manner
- Support planning and monitoring activities, update timelines when necessary and communicate changes to the relevant partners
- Maintain systems and databases per internal SOPs and policies
- Ensure submission packages are reviewed against local CMC requirements for consistency and completeness
- Liaise with the manufacturing sites for obtaining supporting documents as needed
- Work in collaboration across the regulatory organization with stakeholders (such as the global regulatory lead (GRL) and the country regulatory lead (CRL) to deliver efficiencies in Regulatory submissions and processes
Your profile
- Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences
- Profound experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance
- Strong knowledge / background of EU regulatory procedures, requirements and of Europe submission product lifecycle management processes
- Knowledge of drug development practice, rules, regulations and guidelines
- Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards
- Demonstrated experience of effective delivery in a matrix environment
Your benefits
- Work in an international environment
About Hays
With over 15 years of experience in the pharmaceutical industry, 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 professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
Staffing process for a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Your contact at Hays
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