- The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopedics.
- Our company has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
Ensure right first time submissions, decreasing implementation lead-times (e.g. time to market). Contribute to CMC regulatory compliance of operations.
- Draft and/or update CTD quality documents during product life-cycle (registrations in new markets, variations, line extensions, license renewals..).
- Review CTD quality documents prepared by R&D and Product Supply/Manufacturing sites
- Provide advice/input to project meetings related to regulatory technical requirements in cooperation with Global Regulatory Affairs (GRA)
- Support GRA and the CMC regulatory colleagues in Product Supply with the external CMC Regulatory Surveillance activity
- Supports sites with the regulatory workload of Third Party Manufacturers
- Help GRA and manufacturing sites to answer to technical questions raised by regulatory agencies during product registration procedures
Required Experience & Skills
- Scientific degree (pharmacy, chemistry, biology or equivalent)
- Significant practice (+5 years) of the registration procedures for new applications, variations, line extensions and transfers of pharmaceutical products.
- Significant practice (+5 years) of CTD scientific writing (CMC) in English for EU, US, JP and RoW countries.
- Good knowledge of manufacturing process and control methods for pharmaceutical products.
- Excellent knowledge and ability to interpret ICH regulatory guidelines.
- Good knowledge of the pharmaceutical GMP environment including Change Management.
- Oriented to regulatory compliance. Ability to write in a concise way.
- Organised and able to handle several tasks simultaneously and accurately.
Interpersonal skills, team worker.