Global Regulatory Affairs Manager
vor 2 Wochen
You will be responsible for regulatory activities required at a country level for pharmaceutical products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable market(s) As part of the IQVIA Regulatory Affairs & Drug Development Solutions department, you will be working with our clients - global pharmaceutical companies.
**JOB OVERVIEW**
**Essential Functions**
- Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries
- Preparation of local Product Labelling (e.g. SmPC, PIL), in local language for designated countries - Artwork review and approval in client systems
- Manage multiple pharmaceutical products
- Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned and discuss customer comments.
- Acts as a Subject matter expert in Regulatory knowledge in Chemistry, Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.
- Project budget management
- Give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development
- Possible exposure to present to clients on complex regulatory processes bid defense meetings
- Act as reviewer for regulatory standard operating procedures
- Prepare and deliver internal regulatory training if required
**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
- Experience Typically requires 8-10+ years of prior relevant experience. Education Master's Degree in Life science or related discipline Skills and Abilities
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls) relevant regulatory guideline related guidelines
- Possesses a specific regulatory or technical expertise
- Interpersonal communication (oral and written) and organization skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Demonstrates self-motivation and enthusiasm
- Ability to adapt quickly to a rapidly changing environment
- Knowledge of Maintenance of marking Authorization
- Experience of preparing variation, renewal packages and artwork approvals.
- Fluent in English language and able to effectively communicate complex business language to those who speak English as a second language.
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