# Regulatory Affairs Team Lead

- **Entreprise** : [PRODUCTLIFE GROUP](https://www.keejob.com/offres-emploi/entreprises/23145/productlife-group/)
- **Lieu** : Tunis, Tunisie
- **Type de contrat** : CDI
- **Niveau d'études** : Bac + 5
- **Expérience** : Entre 5 et 10 ans
- **Langues** : Français, Anglais
- **Métiers** : Pharmacien
- **Date de publication** : 2022-07-29
- **Date d'expiration** : 2022-07-29
- **Référence Keejob** : 160178
- **Statut** : Offre expirée

## Description

We are seeking a Regulatory Affairs Team Lead with Coordination and Team Management skillset  who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:

Responsibilities

  * To contribute to the production of client administrative documents and reports to be included in regulatory submissions
  * Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
  * Systems Management and Administration
  * Document and track regulatory submissions and regulatory authority approval
  * Gain regulatory authority approval
  * Provide regulatory support to clients and associate companies
  * Assess regulation and inform the clients about the impact on their products or activities
  * Liaise with sponsor head-office and affiliate departments on regulatory issues as well as external regulatory authorities when required
  * Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labeling
  * Review tasks for, support, and mentor Regulatory Affairs Associates/Officers
  * Provide ongoing regulatory support to the Coordinator and the teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
  * Contribute to data entry in PLG tools enabling measurements of KPI and metrics for regulatory services supplied by the platform/hub
  * Control that invoicing is correctly set
  * Assist the RA Platform or Hub Leader or Coordinator in presales:
  * Ensure providing technical support to presales
  * Ensure adequate technical description of the proposals and support sales for quotation evaluation

Profile and Skills

  * Master or higher graduate degree in a science-related field, or equivalent experience along with experience in Project management/ Team Management or Coordinator skillset
  * Min 5-8 years of experience in a regulatory affairs department required + relevant experience in EU regulations
  * Strong coordination skills and leadership
  * Client communication and facing experience
  * Excellent communication skills in English (written fluency a must, verbal fluency preferred)
  * Excellent organizational and interpersonal skills
  * Good computer skills and the ability to learn appropriate software
  * Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
  * Ability to work well and lead a team
  * Process orientated with good attention to detail
  * Sense of responsibility and meeting deadlines
  * Pro-active attitude and ability to work on own initiative as well as part of a team
  * Ability to prioritize different workloads/multi-task
  * Personal responsibility for ensuring a high standard of work

## Postuler

Cette offre n'est plus active. Page de l'offre : https://www.keejob.com/offres-emploi/160178/regulatory-affairs-team-lead/

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Source : Keejob.com, le site de l'emploi en Tunisie.