REGULATORY AFFAIRS OFFICER (M/F)

Job description

Entreprise:ProductLife Group
ProductLife Group is helping international life sciences organisations to more effectively get their products and therapies to market by providing clients functional support across all of the regulated stages of the product life cycle—from development to launch, to postmarketing.
Poste et missions:
- Ensure the regulatory activities of the regulatory Hub . Activities include pre-registration activities, the new registration (sites and medicines), post licensing, regulatory submissions, interaction with the health authorities on behalf of clients PLG.
- Compile regulatory files respecting national requirements
- Obtain approval from regulatory authorities.
- Provides on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
- Provide regulatory support to clients and associates
- Liaise with external regulators as required
- Provide format and contents review of packaging texts, Summary of Product Characteristics and labelling
- Contribute to the data entry of the platform / Hub in the PLG tools measurements KPI / metrics for regulatory services supplied
Profil:
- Education: Bachelor’s or higher graduate degree in a science related field
- Experience: 2 years of experience in Regulatory Affairs
- Knowledge of EU registration
- You are fluent in English and French (spoken and written) for daily contacts with local and internationally partners
- Organizational skills
- Pro-activity