Job Description
About The Job
We are seeking a highly motivated and detail-oriented immediate joiners Regulatory Affairs specialist to join our consulting company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally (internationally).
Responsibilities:
Submission and Approval Process:
Preparation and submission of Manufacturing License Application (MLA)
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
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 pharmaceutical company and the regulatory agencies
Support internal requests for information
Experience:
5-8 years of relevant experience in Regulatory Affairs Internationally
Lifecycle maintenance experience
Experience with: MLA, MAA, CTD, Variations, Renewals, Labeling Applications
Experience working with Global Market
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
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.
Please use the below Lifelancer link for job application and quicker response.
https://lifelancer.com/jobs/view/af1ccb6e24237239d1ea927dbd658cc6
