Zonal Regulatory Associate - Emea Bardi

Zonal Regulatory Associate - Emea
Bardi
Emilia Romagna, Bardi

Description**:** Purpose**:

Provides registration support to a Zonal Regulatory Leader (ZTL) for actives and products at EMEA levelfor active ingredient registration (EU registration and renewal of registrations) and for formulationregistration projects.

Provides logístical and administrative support to collate and manage regulatorydossiers.

Provides leadership for producing electronic dossiers (IUCLID, CDRom, CADDY) and facilitatingthe use of Global Dossier Assembler.

**Interacts With**:

- ZRL and members of the Regulatory Team(s), whether permanent or ad-hoc: Country RegulatoryManagers (CRMs), Subject Matter Experts (SMEs), Food Chain Specialists, data managers andexternal CROss,

- CORE

**Key Responsibilities**:

- Support ZRL in clearly defined, delegated tasks and activities according to need, for activesubstance or PPP authorization projects, actively using the l tools and data managementsystems for the regulatory function.

For example:

- Participation to all relevant team (SME, network, manufacturing) meetings, with taskforce

- Collation and review of residue data with SMEs for development and preparation of EUMRL or CODEX packages

- Implementation of defined parts of the regulatory strategy

- Co-ordinate discussions between CRMs and SMEs on identification of cGAP/riskenvelopes

- Working with CRMs to document agreed supported uses and develop registrationresource requirements

- Liaison with SMEs to plan and agree schedule for dossier production

- Liaison with external contractors for regulatory activities such as dossier preparationoInformation gathering for re-registration, line extensions or formulation changes

- Provide information for Emergency Use Permits

- Preparation of Documents in the active substance or PPP dossier owned by Registration(e. g.

GAP, authorized uses)

- Provide logístical and administrative support for active substance or PPP submissions.

Forexample:

- dossier collation and editing

- generation of reference lists

- Use of Global Dossier Assembler

- Liaison with CORE

- Maintenance of documentations (databases and file shares)

- Archiving of appropriate documents in NetDocuments

- Support for meeting EU transparency requirements: Notification of Studies, sanitizationof documents, first point of contact for liaising with CROs on IUCLID

LI-SD1 #LI-Onsite

**Qualifications**:** Qualifications and Skills**:

- Educated to at least BSc level in a biological science, preferably with an additional higher level scientific degree.

- Some regulatory knowledge desirable, but full training will be provided.

- Good communication skills: proactivity, quick learner, self-motivated, attention to detail and well-organised - but also must be an effective team player.

Highly proficient in MS office (especially Word and Excel).

- Good knowledge of written and spoken English.

Another language is a plus.