Senior Specialist Regulatory Registration and Compliance
Senior Specialist Regulatory Registration and Compliance
Posted on :
05-02-2025
Employer Active
1 Vacancy
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Job Description
Key Responsibilities:
- Prepare and manage marketing authorization (MA) submissions including the preparation of local administrative documents quality control (QC) and compilation. Provide ad hoc regulatory advice on submission packages in the postauthorization stage of the medicinal product lifecycle.
- Review and provide linguistic input for local Product Information and Mockups.
- Serve as the primary contact point for regulatory affairs (RA) matters with national competent authorities (NCAs) and/or clients.
- Involvement in project management of the network of local contact persons for Regulatory affairs
- Collect process and manage regulatory intelligence to keep the organization informed of key updates and changes.
- Propose marketing authorization strategies tailored to client needs.
- Act as a deputy for the line manager when required ensuring seamless continuity in leadership and operations.
Qualifications :
- University education in Natural Sciences Chemistry Medicine Pharmacy or Pharmacology
- Previous industry experience is essential
- Knowledge of Regulatory area and applicable legal and other requirements (both local and global) within pharmaceutical industry
- Excellent organizational skills with the ability to manage multiple projects and deadlines.
- A collaborative mindset coupled with excellent communication skills to liaise with clients and regulatory bodies effectively.
- Advanced knowledge of English (both written and verbal)
- Experience with centralised procedures advantageous
- Experience with regulatory databases and dossier management software advantageous
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Key Skills
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