Association Directio....
Association Direction Regulatory Affairs
Posted on :
18-04-2024
Employer Active
1 Vacancy
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Jobs by Experience
0 - 8 years
Monthly Salary
JOD 6000 - 10000
Nationality
Jordanian
Gender
N/A
Vacancy
1 Vacancy
Posted on :
18-04-2024
Job Description
Req ID : 561390
- For assigned products, ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities.
- Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
- For assigned products ensures timely, accurate and compliant labeling review and artwork preparation.
- For assigned products and tasks, stays updated on late pipeline filings, relevant regional and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- For assigned products and tasks, works alongside the BD, locally, regionally and globally, to support business initiatives in sub region.
- Maintains a positive relationship with internal and external regulatory contacts. GRA/RAI on sub-regional, regional and global level, MMD, EEMEA PV and WPS are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
- By discretion of Regulatory Affairs Management and due to organization and workload, all listed activities need not to be performed.
- Applicable to incumbent with direct reports only Responsible for people management of applicable Regulatory personnel in Country and provides clear leadership for these. Secures appropriate career development for the applicable staff and is responsible for keeping the applicable staff scientifically and legally updated within the Regulatory area.
- Acts as substitute for Country Lead Regulatory Affairs as appropriate.
Employment Type
Full Time
Company Industry
Department / Functional Area
Key Skills
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