Job purpose:
The Regulatory Site Support supports regulatory compliance for both clinical and marketed products by means of correct and timely handling of all regulatory CMC activities on our client's Geel manufacturing site.
You manage regulatory activities associated to change controls, deviations and inspections including updating of CMC (Module 2 and 3) files and ensures the role of expert for all regulatory topics and projects on the Geel manufacturing site.
You perform/support the performance of the following activities related to the assigned product(s) as per our client's procedures:
1. Regulatory Compliance
2. Ensure that the CMC dossiers are and stay in line with implemented manufacturing and control procedures on site.
3. Act as regulatory expert within project teams and support project teams by providing accurate regulatory intelligence to ensure that proposals are aligned with current regulatory guidelines and expectations from Health authorities around the world.
4. Review and approval of GMP site documents to ensure these are aligned with registered details and regulatory guidelines. This includes product specific Specification Sheets, Stability Protocols and Reports, Validation and Qualification Protocols and Reports, Analytical and Process Comparability Plans and Reports
5. Change Control and Deviations
6. (Pre-)Asses the regulatory impact of proposed changes and manage their regulatory implications
7. Provide regulatory information as part of deviations to further assess the impact on regulatory compliance.
8. Act as the site’s regulatory interface with with Global Regulatory Affairs or with external partners.
9. CMC and Regulatory Documentation management
10. Support the writing of and/or authors CMC regulatory documents/dossiers and other supporting documents in a timely manner related to both clinical applications, marketing authorization applications and post-approval changes globally
11. Maintenance of Product Licenses and new registrations: this can include supporting periodic Product License renewals, creation of annual Product reports for Health Authorities, site registrations and transfers,…
12. Identify as early as possible, documentation required to support regulatory submissions and potential issues associated with the content, quality and/or timely delivery of these documents
13. Negotiate timely delivery of, high quality, technical source documents in accordance with project time-lines.
14. Supports the writing of and/or authors responses to Information request or deficiency letters received from Health Authorities in a timely manner. Both for CMC dossier related and inspection related queries.
15. Transversal activities
16. Acts as the primary contact person with Global Regulatory Affairs or with external regulatory partners
17. Participate and support site inspections and audits
Profile:
* Master’s degree or equivalent in Pharmaceutical/ Biotech/ Life sciences
* 3-5 years’ experience in the field of Biotech industry,
* Knowledge/experience in CMC Regulatory Affairs
* Knowledge/experience of manufacturing and/or quality operations, interactions with health authorities
* Knowledge/experience in Regulatory registration and maintenance, GMP and health-related regulations
* Highly proficient in English (both oral and written communication).
* Technical and scientific writing skills. Attention for detail.
* Familiar with CTD Dossiers
* Knowledge of ICH, EMA and FDA Guidelines
* Computer skills: Word, Excel, PowerPoint. Experience in Regulatory Information Management systems e.g. Veeva Vault).
* Capable of interacting effectively with other departments of the company network (Global Regulatory Affairs, Global Quality, Supply chain, iCMC,…).
* Ability to prioritize. Deliver against challenging deadlines.
* Analytical thinking, transparent and hands-on troubleshooting style
* Strong interpersonal and communication skills (writing & verbal)
* Ability to work in a matrix organization. Capable of working in a team and familiar with project development through cross-functional activities.
* Good organizational and negotiation skills.
* Ablility to work independently