TRABAJO REGULATORY AFFAIRS CMC CIUDAD DE MÉXICO, CIUDAD DE MÉXICO

Change control: support the site in generation of effective change control strategies from a regulatory affairs cmc perspective... consider current regulatory requirements...

Proven ability to manage regulatory submissions and interactions with regulatory agencies... minimum of 2 years of experience in regulatory affairs within the pharmaceutical...

Partner where required with international regulatory leads (irls), cmc and other functions to support the regulatory strategy, registration, timelines and lifecycle...

Experience: the candidate must have had a previous position in the regulatory affairs area... coordinate, review and approve labeling changes due to regulatory approvals...

• ensuring all required regulatory & tax documentation has been received, validated and escalated where necessary... o ensure that customer record maintenance activities...

Medical affairs manager fixed term (1-year) live what you will do let’s do this... establish and maintain professional and credible relationships with key thought...

• identify potential regulatory trends in the region... • 7+ years of experience in regulatory compliance, banking or non-banking supervision and examination, regulatory...

Previous experience in clinical research or regulatory affairs preferred, but not required... maintaining accurate and up-to-date records of regulatory submissions...

Supports country-level intelligence on start-up (su) and clinical trial regulatory (ctr)... we translate unique clinical, medical affairs and commercial insights...

In coordination with the team, the mis interacts with internal stakeholders to obtain support for handling escalated inquiries and sharing insights on the operation...

•    prepares for and hosts or supports regulatory authority inspections... •    previous experience in supporting customer audits or regulatory inspections in...

Supports local regulatory and ethics approvals for development protocols develops and drives better recruitment strategies in conjunction with local dfo team...

Strong understanding of the pharmaceutical industry, including regulatory requirements, patient access, and reimbursement processes... all employment businesses/agencies...

We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities... qualifications what we’re looking for •  ...

Demonstrated ability to understand how technical language in legislative and regulatory proposals could affect corporate operations, identify business implications...

We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities... •    demonstrated expertise in site management...

• partner within all areas of medical affairs (e... • adhere to all gsk policies and procedures as applicable for msl and medical affairs organization...