Beschreibung
Global Regulatory Submission Publisher (m/f/d)
Reference: -en
Start: asap
Duration: 18 MM++
Main tasks:
- Accountable for all publishing, verification, dispatch and coordination of HA compliant, worldwide regulatory submissions in support of NVS global product portfolios
- Responsible for electronically preparing, publishing, quality reviews, validation and dispatch activities related to regulatory submissions
- Ensure a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
- Ensure compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.
- Assure procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.
- May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.
- May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.
- May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.
Main qualifications
- BS in life sciences or a relevant discipline
- Submission publishing experience in Pharma or related industry
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria
- Effective interpersonal skills, strong written and oral communication and presentation skills
- Project management and time management skills to manage multiple ongoing projects simultaneously
- Familiar with regulatory requirements and HA guidances, including FDA
regulations, ICH and EMA guidelines/directives - Working knowledge of regulatory affairs
- Fluent in English
- Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly.
- Analytical skills and problem solving skills.
- Ability to coordinate and work effectively with cross-functional teams
Main advantages:
- Great and international team
- Global pharma
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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