COE Country Regulatory Associate

The COE Regulatory Associate will report to COE Country Regulatory Manager.

The AMEE RA COE Country associate will be responsible for the post-approval changes dossier evaluation, preparation and dispatch to the countries for submission in line with local regulations and planning set up by Global/Regional BU/Country regulatory team.

In addition there is a specific duty to self-assess risk for the domain of responsibility, and highlight risks to the n+1 direct manager in a timely manner.

KEY RESULTS - ACCOUNTABILITIES

1.Ensure preparation of ready- to- submit regulatory dossier

• According to the country regulatory requirements and planning, assess, coordinate and contribute to the preparation of ready- to- submit regulatory dossier:
  1. Labeling, CMC, administrative, renewal /annual report
  2. Site registration
  3. Tender

and /or any type of response documents to the Health Authorities questions by interacting with the relevant stakeholders (BU region regulatory, GRA, RSO local medical, local Pharmacovigilance department etc.) and monitoring of dossiers dispatch up to submission.

2. Ensure the management of the artworks

• Use of the Vista & VistaVac tools for the management of the artworks
• Download the dossiers to Vista & VistaVac tools

Ensure update the databases (Veeva Vault)

• Update the regulatory events in databases (Veeva Vault)
• Monitor the regulatory events in databases (Veeva Vault)

Ensure the administrative documents related with PoA, CPP

• Prepare the administrative documents related with PoA, CPP by using mail, legalization, translation requests, posting and archiving in the countries concerned and exportation if applicable.

5. Ensure all documents are translated in compliant with Health Authority requirements

• Know the Health Authority requirements
• Ensure all documents are translated in compliant with Health Authority requirements

Ensure regulatory compliance with products and country requirements

• Ensure regulatory compliance with products overall strategies
• Ensure regulatory compliance with Health authorities country requirements evolution

Ensure compliant with all internal and external requirements, procedures and tools

• Be compliant with all internal requirements, procedures and tools
• Be compliant with external requirements, procedures and tools

Implement all activities in timely manner and align with Regional BU/country strategy

• Dispatch in timely manner Regional BU/country planning
• Ensure alignment with RA BU region and country activities

Maintain a good working relationship

• Maintain a good working relationship with internal and external stakeholders
• Be a business partner for the BU/Country regulatory team
• Be a business partner for Global CMC&Devices, Global Labeling, RSOs

Foster an environment/culture of learning and sharing of best practice within the team

• Ensure learning and sharing of best practice within the team

11. Maintain Compliance (Manadatory item for all )

• Abide by the requirements of the Code of Ethics including but not restricted to maintaining high professional standards of conduct in line with the Company procedure with a duty of care to the reputation of the Company

12.Ethical Leadership (Manadatory item for all )

• Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (Sanofi Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.
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