Gra Ra Eu and International Specialist

3 settimane fa

Parma, Italia IQVIA A tempo pieno

Our client, **Chiesi Farmaceutici **- one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of a **GRA RA EU and International Specialist **who can join an exciting working environment in a dynamic and international atmosphere.

**RESPONSABILITIES**:

- Under guidance of the regional Head, prepares, compiles, and maintains regulatory documents to support a broad range of submissions to regional regulatory authorities within a given timeline.
- In collaboration with consultants, partners and affiliates, plans, coordinates, and manages regulatory submissions to regional agencies throughout the life cycle of Global Rare Disease products.
- Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., makes recommendations for improvement and ensures adequacy for submission.
- Contributes to the development of processes and the preparation of Standard Operating Documents for Global Rare Disease RA.
- Upon request of the manager, provides regulatory guidance to colleagues from other functional areas.
- Prepares responses to questions and/or information requests from regulatory agencies within the timeframes specified.
- Liaises with internal customers, and external customers (e.g., staff at the contract manufacturing organizations, partners, affiliates, and contract research organizations) to request and obtain data relevant to submissions.
- Uses data management systems to track regulatory information pertaining to planned activities and life-cycle management of products.

**PROFILE**:

- Experience and knowledge in the life cycle management of regulatory filing.
- 2-year experience in regulatory affairs in EU or INT or both at corporate level in a multinational company
- Ability to work under supervision in the preparation of high-quality submissions and submission documents.
- Strong attention to details and quality of documents and processes.
- Well-developed written and oral communication and listening skills.
- Well-developed time management skills and demonstrated ability to manage complex assignments.
- Well-developed analytical and problem-solving skills.
- Ability to work independently and as part of a team.
- English level from advanced to fluency

TYPE OF CONTRACT:
Maternity leave

Chemical contract

LICES

  • Medical Affairs Operations Specialist Eu&Em

    5 giorni fa

    Parma, Italia Chiesi A tempo pieno

    **Department**:Rare Medical Affairs**Job Type**:Direct Employee**Team**:Mktg, Market Access, Bus.Excellence & Med.Affair**Contract Type**:Permanent**Location**:parma, IT**_About us_**- Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than...

  • Life-cycle Management and Regulatory Compliance

    4 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Department**: Global Regulatory Affairs **Team**: R&D, Pharmacovigilance & Regulatory Affairs **Job Type**: Direct Employee **Contract Type**: Permanent **Location**: parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with...

  • International Welding Engineer

    4 settimane fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for an International Welding Engineer with at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities.The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and supervise...

  • International Welding Engineer

    3 settimane fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for an International Welding Engineer with at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities. The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and supervise...

  • International Welding Engineer

    7 giorni fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for anInternational Welding Engineerwith at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities. The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and supervise...

  • International Welding Engineer

    5 giorni fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for an International Welding Engineer with at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities.The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and...

  • International Welding Engineer

    1 settimana fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for anInternational Welding Engineerwith at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities. The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and supervise...

  • International Welding Engineer

    4 giorni fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for anInternational Welding Engineerwith at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities.The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and supervise...

  • International Welding Engineer

    4 settimane fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for an International Welding Engineer with at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities. The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and...

  • International Welding Engineer

    4 settimane fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for an International Welding Engineer with at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities. The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and...

  • International Welding Engineer

    2 settimane fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for an International Welding Engineer with at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities.The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and supervise...

  • International Welding Engineer

    1 settimana fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for anInternational Welding Engineerwith at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities.The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and supervise...

  • International Welding Engineer

    2 settimane fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for anInternational Welding Engineerwith at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities. The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and supervise...

  • International Welding Engineer

    3 giorni fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for anInternational Welding Engineerwith at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities.The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and supervise...

  • International Welding Engineer

    13 ore fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for an International Welding Engineer with at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities.The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and...

  • Life-Cycle Management And Regulatory Compliance

    4 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Department**: Global Regulatory Affairs**Team**: R&D, Pharmacovigilance & Regulatory Affairs**Job Type**: Direct Employee**Contract Type**: Permanent**Location**:parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than...

  • International Welding Engineer

    1 settimana fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for an International Welding Engineer with at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities. The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and...

  • International Welding Engineer

    3 settimane fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for an International Welding Engineer with at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities. The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and...

  • International Welding Engineer

    11 ore fa

    Parma, Italia Bonatti A tempo pieno

    We are currently looking for an International Welding Engineer with at least five years of experience in oil and gas field, including metallurgical engineering, gained in a construction or fabrication facilities. The resource develop and qualify Procedure Qualification Records (PQR) and related Welding Procedure Specifications (WPS), follow up and...

  • International Welding Specialist

    2 giorni fa

    Parma, Emilia-Romagna, Italia Bonatti A tempo pieno

    Bonatti is committed to promoting an inclusive work environment and respecting gender diversity. We are currently looking for an experienced International Welding Engineer to join our team in Parma. As a key member of our team, you will be responsible for developing and qualifying Procedure Qualification Records (PQR) and related Welding Procedure...