RA Manager
Titel: RA Manager
Werkgever: Hays
Plaats: Provincie Noord-Holland
Provincie:
Locatie:
Provincie Noord-Holland /
Omschrijving:
Regulatory Affairs Manager position for at least a year in North-Holland.
Your new company
Multinational pharmaceutical company in North-Holland. Worldwide this company focusses on discovery, development and innovation of products to prevent and treat diseases, to ease suffering and to enhance the quality of life.
Your new role
Within in position you will provide and manage regulatory support to the company in order to obtain Marketing Authorisations for commercial products as rapidly as possible and to maintain these authorisations post-approval. In addition you will provide input into all stages of the company’s development and portfolio products and develop strategies to ensure a complete and rapid development. You will also manage the preparation of Regulatory Documentation and will be an independent contributor to RA initiatives within the company.. An overview of major responsibilities
- Organize the area of responsibility and managing, training, developing the respective group members.
- Maintain accuracy of budget and budget expenses for his/her group related activities
- Contact point for the concerned products/projects.
- Close co-operation with other concerned functions of the company, e.g. Medical, Commercial, Legal.
(In cases -TechOps/QA/QC on specific product issues or via Reg CMC)
- Collaborate with the other RA functions (e.g. Reg CMC, Reg Operations, Regional RA) regarding regulatory submissions.
- Coordinate regulatory procedures such as clinical trials applications, IND submissions and amendments, marketing and manufacturing authorisation applications, variations, annual reports, renewals, etc.
- Collaborate with 3rd parties regarding regulatory maintenance
- Sit on designated project teams and providing regulatory input to these teams including preparation of draft position papers on regulatory issues, draft regulatory sections of project plans and suggested regulatory strategies.
- Provide regulatory advice within the framework of the company’s Change Control procedure, and to support the company’s regulatory compliance personnel.
- Regulatory approval of promotional material as required and helping to resolve external medical/technical enquiries.
- Development and review of product labels.
- Assist in the maintenance of the regulatory database and other regulatory information management lists
- Is responsible to track variations in sentry in a timely manner
- Identify regulatory opportunities or issues and problems related to designated products/projects and recommending solutions
- Upon agreement with the RA Franchise Head, represent the franchise at GPT meetings. What you'll need to succeed A scientific degree in an appropriate biomedical subject (e.g. Pharmacy, Pharmacology, Chemistry, Biology, Medicine, etc.) is required Excellent knowledge of written and spoken English A minimum of 5 years work experience with Pharmaceutical Regulatory Affairs. Knowledge of worldwide regulatory procedures and requirements. Good communication and influencing skills. Good adaptability skills. Good managerial and interpersonal skills. What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Interesse?
Stuur ons dan je CV en motivatie toe door te klikken op onderstaande knop "Reageer op deze vacature".
Provincie Noord-Holland /
Omschrijving:
Regulatory Affairs Manager position for at least a year in North-Holland.
Your new company
Multinational pharmaceutical company in North-Holland. Worldwide this company focusses on discovery, development and innovation of products to prevent and treat diseases, to ease suffering and to enhance the quality of life.
Your new role
Within in position you will provide and manage regulatory support to the company in order to obtain Marketing Authorisations for commercial products as rapidly as possible and to maintain these authorisations post-approval. In addition you will provide input into all stages of the company’s development and portfolio products and develop strategies to ensure a complete and rapid development. You will also manage the preparation of Regulatory Documentation and will be an independent contributor to RA initiatives within the company.. An overview of major responsibilities
- Organize the area of responsibility and managing, training, developing the respective group members.
- Maintain accuracy of budget and budget expenses for his/her group related activities
- Contact point for the concerned products/projects.
- Close co-operation with other concerned functions of the company, e.g. Medical, Commercial, Legal.
(In cases -TechOps/QA/QC on specific product issues or via Reg CMC)
- Collaborate with the other RA functions (e.g. Reg CMC, Reg Operations, Regional RA) regarding regulatory submissions.
- Coordinate regulatory procedures such as clinical trials applications, IND submissions and amendments, marketing and manufacturing authorisation applications, variations, annual reports, renewals, etc.
- Collaborate with 3rd parties regarding regulatory maintenance
- Sit on designated project teams and providing regulatory input to these teams including preparation of draft position papers on regulatory issues, draft regulatory sections of project plans and suggested regulatory strategies.
- Provide regulatory advice within the framework of the company’s Change Control procedure, and to support the company’s regulatory compliance personnel.
- Regulatory approval of promotional material as required and helping to resolve external medical/technical enquiries.
- Development and review of product labels.
- Assist in the maintenance of the regulatory database and other regulatory information management lists
- Is responsible to track variations in sentry in a timely manner
- Identify regulatory opportunities or issues and problems related to designated products/projects and recommending solutions
- Upon agreement with the RA Franchise Head, represent the franchise at GPT meetings. What you'll need to succeed A scientific degree in an appropriate biomedical subject (e.g. Pharmacy, Pharmacology, Chemistry, Biology, Medicine, etc.) is required Excellent knowledge of written and spoken English A minimum of 5 years work experience with Pharmaceutical Regulatory Affairs. Knowledge of worldwide regulatory procedures and requirements. Good communication and influencing skills. Good adaptability skills. Good managerial and interpersonal skills. What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Interesse?
Stuur ons dan je CV en motivatie toe door te klikken op onderstaande knop "Reageer op deze vacature".
