MAIN ACTIVITIES FOR THE JOB
- 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 Specialist and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
- Supporting seniors (RAS) for Initial MA application, all kind of LCM activities including minor/major variations, renewals, sunset clause, labelling changes, Article 61.3, MA transfers, Manufacturing etc.
- Have experience of preparing the Module 1 of pre and/or post approval applications.
- Contribute to data entry in PLG tools enabling measurements of KPI and metrics for regulatory services supplied by the platform/hub.
Required education:
Bachelor's or higher degree in a science related field, or equivalent experience
Required experience:
4-6 years of experience in RA European Regulation
Required languages:
- Good English language and grammar skills (written fluency a must, verbal fluency preferr
- ed)Any other language on top of good English would be a plus
Required technical skills:
- Good computer skills and the ability to learn appropriate software
- Good understanding of regulatory tracking database software, MS Word, MS Excel, MS PowerPoint etc.
Additional experience and/or skills:
- Excellent organizational and interpersonal skills
- Ability to work well within a team
- Process orientated with good attention to detail
