Manager/Director, Technical Regulatory managing regulatory submissions for pharmaceutical products. Ensuring compliance with local and global standards in order to support timely approvals.
About the role
- Regulatory Affairs Manager for Novonesis overseeing Household Care portfolio compliance in LATAM. Driving regulatory strategies and managing product documentation for safe biosolutions.
Responsibilities
- Drive regulatory strategies for Household Care & Industrial (HHC & I) across the Americas and Bioenergy in LATAM to secure timely approvals and compliance.
- Monitor chemical regulations in Brazil, Colombia, Peru and Chile; represent NVS RA HHC & I in external working groups and trade associations.
- Lead preparation of dossiers for new registrations and renewals.
- Support annual tonnage reporting for the Americas.
- Ensure product documentation (SDS, labels, technical files) meets regional and global standards.
- Manage regulatory data in RegOne and internal systems.
- Coordinate documentation with global and local teams for submissions.
- Support chemical inventory management and tracking of regulatory status in North America (NA) and LATAM.
- Engage early with local stakeholders to ensure proactive regulatory alignment.
Requirements
- Bachelor’s degree in a relevant field such as Biotechnology, Biology, Chemistry, Microbiology, or other related scientific disciplines.
- Over 7 years of regulatory experience, with extensive background in the household care industry or related sectors.
- Experience representing the company in trade associations and interacting with local regulatory authorities (e.g., ANVISA, CTNBio, VISA, among others).
- GMM (Genetically Modified Microorganisms) dossier expertise is a plus.
- Ability to translate biotechnology concepts into regulatory terms.
- Clear communicator with strong stakeholder engagement skills.
- Proactive, results-oriented, and quick to adapt.
- Comfortable working independently and collaboratively as part of a team.
- Experience coordinating with global teams.
- Fluent in Portuguese, Spanish and English (reading, writing and speaking).
Benefits
- Health and wellness benefits
- Professional development opportunities
- Flexible working hours
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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