- Give support with registration products, renewals, update CMC, update labeling for products giving support in the review of promotional materials, Tender Bids and other activities related to this business unit.
- Prepare Targeting Annual Plan for registration corresponding to the Business Area in charge in order to develop the best strategy for effective efforts.
- Give support to the team regulatory in order to ensure the preparation, submission and follow up of all documents for Product Registration involved with renewals, update labeling, update CMC, Change source of supply and manufacturing site when is required for Business Unit assigned
- Be aware of current Law and regulation to ensure that all products meet required statutory and regulatory requirements, as well as assuring that registration are complete.
- Establish sound communications and working relationships with corporate personnel, as well as with all other external supplies , legal counsel, regulatory agencies, environmental agencies, professional and trade associations, and , in general, strive to uphold a professional stance in representation of MSD at all times.
- Protect the company’s proprietary information by insuring confidential information is not released to individuals, except on a need-to-know basis, and, when properly covered with appropriate confidentiality agreements. Insure that said agreements are executed in a timely manner and assume responsibility for their execution.
- Prepare submit and follow up documents to Regulatory Agency responding promptly to any inquiry they may arise related to registered products.
- Negotiating with the Regulatory Agency when is required under the direction of the Regulatory Affair Local Lead.
- Assurance complete the procedure to prepare, submit, approve all artworks corresponding to the Business Unit assigned.
- Give support in the Tender Bids getting CPP's, Exclusivity Letters, Registration Certificate with the certification of valid from Health Authority and all support
- Review and approval the promotional materials to be use in the Business Unit assigned
- Back up in absence of Regulatory Affairs Lead.
- Responsible by Proofreading in the artworks, Leaflet, circular product (Second Reviewer)
- ORION System - responsible by update and verification
• Education: Pharmacyst or Chemical Pharmacyst
• Experience 6 or more years in Regulatory Affairs in the Pharmaceutical Industry
• English: Advanced Oral and Written
• Experience with artworks development
• Experience with proofreading techniques
• Experience with registration databases
• Desirable: Experience using Orwing and MSD Blue tools
Job: Regulatory Affairs Generic Job Title:Assoc. Dir, Regulatory Affairs
Primary Location: LATAM-Mexico-Mexico City-Benito Juárez
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Regulatory Affairs, Law, Copy Editor, Proofreading, Chemical Research, Legal, Creative, Engineering