REGULATORY AFFAIRS OFFICER M/F - Groupe Product Life - Wizbii

REGULATORY AFFAIRS OFFICER M/F

  • By Groupe Product Life
  • V.I.E.
  • December 2018
  • Master, Titre d'ingénieur, Bac +5
2018-08-06T12:19:59+0000

Job description

ProductLife Group is the leading, proven and trusted Pan-European specialist-outsourcing-services provider for the regulatory, safety and quality functions of the life sciences and cosmetics industries.
Through the optimum deployment of people and intellectual assets, we enable clients to achieve greater R&D effectiveness, significant cost reduction in capital and revenue terms, and improved operational speed and efficiency — all of them at the highest level of quality.
Those performance-enhancing improvements are delivered through a blend of the highest-calibre people performing the highest-quality services comprising in-sourcing, functional outsourcing, strategic business process outsourcing and consultancy based on deep domain expertise and thought leadership.
We have three main areas of intervention:
1. Regulatory Affairs and Operations
2. Pharmacovigilance and Safety
3. Pharmaceutical Development & Quality
See also www.productlifegroup.com
To support our double-digit growth in Belgium we are looking for motivated colleagues, eager to learn, keen to work client-facing, and who have the ambition and potential for growth in our dynamic and international organization.
Job purpose:
To have responsibility for allocated tasks within the Regulatory Affairs activities delivered by the Platform/the Hub
Under monitoring of a RA Manager, to have responsibility for allocated projects within the Regulatory Affairs function.
Key responsibilities:
- Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers
- 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.
- Liaise with sponsor head-office and affiliate departments on regulatory issues.
- Liaise with external regulatory authorities as required.
- Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling.
- Review tasks for, support and mentor Regulatory Affairs Associates.
- Provide on-going regulatory support to the Regulatory Affairs Manager and to project 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
Others:
- To assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
- To participate in training as required for ProductLife staff
- To support the Pharmacovigilance group in the production of Regulatory Authority and Ethics Committee documentation.
- To liaise with other group companies on regulatory issues and to provide support for their activities in the regulatory field.
- quality and business requirements within the overall strategy and objectives.
- Contribute to follow up of the quality of service of regulatory partners working with the Platform/the Hub.
- To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives
Requirements & competencies:
- Education: minimum bachelor degree
- Good computer skills
- Fluent in English, Dutch and French
- Focused on quality and being accurate.
- Able to manage projects independently.
- Flexible in time and work.
- Willing to learn and take initiative.
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