Regulatory Affairs Analyst - Temporary 15 months
Job Summary
Job Description
This is a temporary 15-month role to collaborate on projects and activities that will add value to the company. This position is responsible for contributing to the development of robust regulatory strategies and their implementation before the Regulatory Agency to obtain and maintain updated registration authorizations. Additionally, it is responsible for tracking all projects under its charge.
Must have:
- Contribute to defining, redefining, and implementing regulatory strategies.
- Plan, organize, and execute regulatory activities for new registration authorizations.
- Responsible for end-to-end dossier creation.
- Create, review, and approve labeling text per local regulations and global processes.
- Ensure timely submission of additional data as required by the Regulatory Agency.
- Plan, organize, and execute regulatory activities for registration renewal approvals.
- Participate in developing optimal renewal strategies considering future variations.
- Ensure complete data acquisition upon deficiency letters from the Regulatory Agency.
- Provide follow-up for legal and technical documents from International RA CMC and Quality.
- Maintain updated registration files.
- Plan and execute regulatory activities for variations (notifications/authorizations) of marketed products.
- Review and approve artwork according to global packaging management.
- Support submission of stock shortage notifications for products and materials.
- Update internal regulatory databases.
- Create periodic regulatory reports and metrics.
Good to have:
- Proactivity
- Extreme attention to detail
- Excellent attitude and willingness to learn
- Clear communication with different areas. Ability to interact with multiple areas and third parties
- Good command of Excel (Medium-High), Word (High), and Power Point (Medium-High)
2 skills required
Job Details
Temporary 15-month role to collaborate on projects and activities that will add value to the company.
Purpose of the role:
This position is responsible for contributing to the development of robust regulatory strategies and their implementation before the Regulatory Agency to obtain and maintain updated registration authorizations. Additionally, it is responsible for tracking all projects under its charge.
Responsibilities:
- Contributes to the definition, redefinition, and implementation of regulatory strategies in agreement with their manager and the internal areas involved.
- Plans, organizes, and carries out all necessary regulatory activities to obtain new registration authorizations.
- Is in charge of dossier creation from beginning to end.
- Creates, reviews, and approves labeling text in accordance with local regulation, the global package management process, and local procedures.
- Ensures the proper introduction of additional data, within the best deadlines, when required by the Regulatory Agency.
- Plans, organizes, and carries out all regulatory activities to obtain registration renewal approvals.
- Participates in the development of the best renewal strategy considering future variations in the plan and all dynamic regulatory circumstances of the product involved.
- Ensures the obtaining of complete data if we receive deficiency letters issued by the Regulatory Agency.
- Provides follow up to obtain of legal and technical documents required with International RA CMC and Quality (LOC & CMO).
- Provides follow-up to obtain the legal and technical documents required with International RA CMC and Quality (LOC & CMO).
- Maintain registration files properly updated.
- Plans, organizes, and carries out all regulatory activities to obtain approvals for variations (notifications or authorizations) of marketed products related to: formula, manufacturing process, labeling information, packaging, shelf-life extensions, line extensions, site changes, new indications, prescription information updates, etc.
- Reviews and approves artwork in accordance with the global packaging management process.
- Supports the submission of stock shortage notifications for products and materials in accordance with current authorizations and in line with demand needs.
- Updating internal regulation databases.
- Creates periodic regulatory reports and metrics.
Requirements:
- Bachelor's degree in science areas (Chemical, Pharmacy, Microbiological, Biological)
- Minimum 3 to 5 years of experience in the Regulatory Affairs area
- Intermediate English level
Skills:
- Proactivity
- Extreme attention to detail
- Excellent attitude and willingness to learn
- Clear communication with different areas. Ability to interact with multiple areas and third parties
- Good command of Excel (Medium-High), Word (High), and Power Point (Medium-High)
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About The Company
Hello. We’re Haleon. A new world-leadingconsumer healthcarecompany. Shaped by all of us. Together, we’re improving everyday health for millions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol,Advil, Voltaren,Theraflu, Otrivin,and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re building together. In anenvironment thatwe’re co-creating. And a culture that’s uniquely ours. Care to join us.
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