**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Here’s What You’ll Do**:
- Works with general regulatory lead(s), regulatory strategists, Global Regulatory Sub-Teams and project teams regarding the development and execution of regulatory strategy through the product development lifecycle.
- Coordinate, develop and contribute to content and format of regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, pediatric plans, DSURs, MAA/BLA/NDA, etc.
- Identify and assess regulatory risks for assigned projects or programs.
- Senior Manager may serve as point of contact with regulatory agencies relevant to assigned projects or programs, as appropriate.
- Ability to work both independently and within project teams, committees, etc. to achieve group goals.
- Accountable for tracking, following up and archiving correspondence, regulatory commitments, and queries from Health Agencies
**Here’s What You’ll Bring to the Table**:
- BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.




- 5+ years of experience in the Pharmaceutical industry preferred in LATAM Countries.
- 3+ years of experience in Regulatory strategy or relevant training/experience preferred
- Experience in Infectious Diseases and/or Biologicals is preferred
- Strong knowledge of current US and EU regulations
- Strong experience with CTD format and content of regulatory filings
- Exceptional written and oral communication in English and Spanish. Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance
-preferably from at least both US and EU
- Demonstrate strong organizational skills, including the ability to prioritize workload.
- Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
- Experience in authoring regulatory documents
- Knowledge and understanding of applicable regulations.
- Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.

📌 Manager/senior Manager Regulatory Affairs (México)
🏢 Thermo Fisher Scientific
📍 México