Site Regulatory Quality Manager

Ipsen is a fast-growing **biopharmaceutical **group specialising in the **development of innovative medicines** for oncology, neuroscience, and rare diseases. Our goal is to improve the quality of life of patients by finding new solutions to targeted disabling diseases.

As part of the Global Quality organisation in charge of **Pharmaceutical Development**, the **Site Regulatory Quality Manager** will actively contribute to our strategy of becoming a center of excellence for the development of new products at our **3 European sites** (Dreux, Dublin, Wrexham). The role will also encompass:

- Ensure regulatory compliance of **pharmaceutical development** activities throughout the organisation.
- Ensure the **regulatory compliance** of the IPSEN PharmSciences - Dreux **pharmaceutical facility** (inventory, import & export of IMPs, contact with health authorities, etc.).
- Act as the **main contact** for IPSEN's regulatory departments in charge of the CMC part of regulatory dossiers and clinical trial authorization submissions.
- Provide **operational regulatory support** to Qualified Persons in charge of IMP batch certification.
- Be responsible for the **regulatory and legislative monitoring** process for Quality.
- Represent Quality in CMC project groups and contribute to **define the quality requirements** applicable to products at different stages of **clinical development**.
- Act as **Quality project manager** for projects with a regulatory focus or cross-functional international projects covering the entire pharmaceutical development organisation

**Main duties & responsibilities**:
**Regulatory compliance of development activities**
- Coordinate the selection of investigational drugs for clinical studies, with the support of the Global Clinical Supply Chain, CMC Regulatory, Global Regulatory Affairs and Product Quality departments.
- Ensure compliance of product-quality documentation (analytical specifications, product specification file, manufacturing instructions) with regulatory dossiers (IMPD/IND).
- Provide expertise on the interpretation of regulatory texts applicable to pharmaceutical development activities.
- Participate in annual quality reviews by making available regulatory elements relating to products and regulatory activity.
- Ensure and/or implement the regulatory compliance verification process at all pharmaceutical development sites.

**Compliance of the IPSEN Pharmsiences Dreux pharmaceutical facility**
- As Process owner of the pharmaceutical site inventory for IPSEN Pharmsiences Dreux:

- Coordinate with the various IPSEN Pharmsciences departments to collect the information needed to compile site regulatory files (annual inventory, modification file, etc.).
- Verify all information in the site inventory, before approval by all parties involved and submission to ANSM.
- Act as the main contact for regulatory authorities
- Ensure the process complies with regulations.
- Train users
- Evaluate the regulatory impact of change controls carried out on the IPSEN Pharmsciences site.

**Main contact for IPSEN regulatory departments**
- Evaluate the regulatory impact of change controls carried out on products used in clinical studies, in coordination with the CMC regulatory department.
- Act as the local interface for providing information on the status of regulatory dossiers for clinical studies (IMPD, IND, etc.), so that Qualified Person pharmacists can certify batches of investigational medicinal products.

**Regulatory operational support for QPs**

**Regulatory monitoring**
- As Process Owner of the regulatory and legislative monitoring in the fields of activity present on pharmaceutical development sites such as GMP, GCP, EU CTR, ICH...
- Coordinate the impact analysis of new regulations, as well as the creation and implementation of an action plan to bring pharmaceutical development sites into compliance, with the support of experts from the relevant departments.
- Maintain the list of standards applicable to IPSEN Pharm sciences activities.

**Additional duties**:
**Quality representative in CMC project groups**
- Act as Quality representative on molecular projects, defining quality requirements and providing support to ensure that project deliverables are met.
- Act as coordinator between the various functions of the Quality department.
- Follow up projects with quality assurance management.

**Quality Project Manager**
- Take charge of or contribute to projects within the Quality Department or externally by representing Quality Assurance Development Pharmaceutical Dreux,

**Participate in the performance and continuous improvement of Quality activities and processes**
- Participate in the implementation and monitoring of performance indicators in his/her field of activity.
- Contribute to inspections by regulatory authorities (ANSM, FDA, etc.), partner audits and Ipsen corporate audits as quality expert and process owner.
- Propose and participate in Quality communication on the si