Regulatory Affairs Specialist
Welcome to the Latest Job Vacancies Site 2024 and at this time we would like to inform you of the Latest Job Vacancies from the ProductLife Group with the position of Regulatory Affairs Specialist - ProductLife Group which was opened this.
If this job matches your qualifications, please send your application directly through our latest Job site. Indeed, every job is not easy to apply because it must meet several qualifications and requirements that we must meet in accordance with the standard criteria of the Company who are looking for potential candidates to work. Good job information Regulatory Affairs Specialist - ProductLife Group below matches your qualifications. Good Luck: D
Experience in people management/coordination is a plus. Experience in promotional/non-promotional activities is a plus....
Responsibilities
Submission and Approval Process:
Preparation and submission of Technical/Site Transfer Applications
Preparation and submission of Marketing Authorisation Applications
Lifecycle Maintenance:
Preparation and submission of documentation for post-approval applications including, but not limited to, Variations, Renewals, MAH Transfers/COAs, Labeling
Management of artwork generation, labeling, creation, and update of product information
Compliance:
Monitor and maintain up-to-date knowledge of national, European, and International guidelines/legislation
Ensuring compliance with all regulatory processes, in readiness for both internal and external audits
Ensuring compliance with the regulations of the assigned Countries within European and International Regions
Communication:
Act as a liaison between the PLG, PLG clients, and the regulatory agencies
Support internal requests for information
Experience
5-8 years of relevant experience in Regulatory Affairs Internationally
3-5 years of experience in the management of artwork generation, labeling, creation, update of product information
Experience with: MLA, MAA, CTD, Variations, Renewals, Labeling, MAH Applications
Experience working with EU region would be beneficial
Experience with software packages and databases (Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc.)
Good organizational skills and communication skills
Ability to prioritize and deliver high-quality work
Experience in people management/coordination is a plus
Experience in promotional/non-promotional activities is a plus
Information :
- Company : ProductLife Group
- Position : Regulatory Affairs Specialist
- Location : Hjemmearbejdsplads
- Country : DK
How to Submit an Application:
After reading and knowing the criteria and minimum requirements for qualifications that have been explained from the Regulatory Affairs Specialist job info - ProductLife Group Hjemmearbejdsplads above, thus jobseekers who feel they have not met the requirements including education, age, etc. and really feel interested in the latest job vacancies Regulatory Affairs Specialist job info - ProductLife Group Hjemmearbejdsplads in 22-05-2024 above, should as soon as possible complete and compile a job application file such as a job application letter, CV or curriculum vitae, FC diploma and transcripts and other supplements as described above, in order to register and take part in the admission selection for new employees in the company referred to, sent via the Next Page link below.
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Post Date : 22-05-2024
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