Sr. Associate I, Regulatory Affairs Strategy
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Job Location:
Mexico City - Mexico
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Sr. Associate I Regulatory Affairs Strategy
Mexico City On-site
At Alcon we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly champion progress and act with speed as the global leader in eye care. Here youll be recognized for your commitment and contributions and see your career like never before. Together we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse talented people to join Alcon.
Role Overview
As aSr. Associate I Regulatory Affairs Strategy supporting the Quality & Regulatory Affairs team you will be trusted to support regulatory strategy submissions and compliance activities for Mexico ensuring our pharmaceutical and medical device portfolio meets local regulatory requirements.
In this role a typical day will include:
Collaborating with cross-functional stakeholders (Quality Medical Affairs Marketing Manufacturing and Global Regulatory teams) to ensure timely and compliant product submissions renewals and variations
Coordinating regulatory submissions with plants agents and regulatory authorities in Mexico ensuring accuracy and adherence to timelines
Supporting regulatory strategies for new product introductions and lifecycle management activities
Reviewing and approving promotional materials to ensure compliance with applicable laws codes and ethical standards
Ensuring adherence to GxP standards maintaining accurate documentation and supporting continuous improvement initiatives
WHAT YOULL BRING TO ALCON
Bachelors degree in Medical-Biological Sciences Chemistry Pharmacy Pharmacology or related field
Experience in Regulatory Affairs within pharmaceutical and/or medical device industries
Knowledge of Mexican regulatory framework and product registration processes
Understanding of pharmacovigilance processes
Intermediate English (oral and written) with ability to interact with global stakeholders
Strong analytical mindset and attention to detail
Ability to manage multiple priorities in a dynamic fast-paced environment
High level of organization resilience and commitment to quality and compliance
HOW YOU CAN THRIVE AT ALCON
Exposure to a diverse pharmaceutical and medical device portfolio within a global organization
Opportunity to contribute to regulatory strategies that directly impact patient access to innovative eye care solutions
Collaborative leadership environment with autonomy accountability and strong cross-functional partnership
Alcon Careers
See your impact at Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.
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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status.
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.
