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Mexico
ProductLife Group Hiring for Regulatory Affairs Officer M/F – 714 Job at Trabajo desde casa Full Time
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In the context of a new project, we are looking for a Regulatory Affairs Associate to join our teams in Mexico.
Responsibilities
Assisting with the preparation of LATAM Marketing Authorisation Applications
Preparation and submission of documentation for post-authorisation activities
Preparation and submission of Technical/Site Transfer Applications
Providing support during external and unannounced audits.
Responding to internal requests for technical and/or regulatory information.
Assisting with license applications as required.
Monitoring and maintaining up-to-date knowledge of national guidelines/legislation (in Mexico, Guatemala, Panama, Dominican Republic).
Ensuring compliance with the regulations of the LATAM region
Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
Using a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data
Realizing general regulatory administration duties and compliance requirements
Ensuring the management of artwork generation
Education & Experience
Bachelor’s or higher graduate degree in a science related field, or equivalent experience
2 to 4 years of experience in Regulatory Affairs
Experience in LATAM regulations and lifecycle maintenance
Profile
Hard/Technical skills:
Knowledge of LATAM regulations (Mexico, Guatemala, Panama, Dominican Republic) for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products
Good understanding of regulatory tracking database software (Register, LorenZ, Trackwise), MS office, VeeVa (or comparable eDMS), etc
Fluency in Spanish
Good command of English to communicate with clients
Soft skills:
Excellent organizational and coordination skills
Ability to work well within a team
Process oriented with good attention to detail
Effective oral and written communication skills
A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
Job Type: Full-time
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